Company · US
B. Braun Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2026. Name variants (Inc, Corp, punctuation) are merged.
153510(k) clearances (3 in 12 months)
510recalls (138 in 12 months)
350recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 257 |
| BSO | Catheter, Conduction, Anesthetic | 99 |
| FRN | Pump, Infusion | 33 |
| OGE | Epidural Anesthesia Kit | 22 |
| DYG | Catheter, Flow Directed | 21 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 17 |
| LHI | Set, I.V. Fluid Transfer | 17 |
| FMG | Stopcock, I.V. Set | 16 |
| FMI | Needle, Hypodermic, Single Lumen | 15 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 14 |
| DYB | Introducer, Catheter | 13 |
| OFT | Spinal Epidural Anesthesia Kit | 13 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 10 |
| CAZ | Anesthesia Conduction Kit | 9 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 8 |
| FMF | Syringe, Piston | 8 |
| FRO | Dressing, Wound, Drug | 8 |
| BXN | Stimulator, Nerve, Battery-Powered | 5 |
| DXT | Injector And Syringe, Angiographic | 5 |
| LCJ | Tissue Expander And Accessories | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K260261 | Gravity Blood Sets with 200µm Filter B.Braun Medical, Inc. | FPA |
| Sep 10, 2026 | K254111 | Irrigation/Urology Sets B.Braun Medical, Inc. | LJH |
| May 15, 2026 | K253235 | Introcan Safety® Deep Access XL IV Catheter B.Braun Medical, Inc. | FOZ |
| Jul 24, 2025 | K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets B.Braun Medical, Inc. | FPA |
| Jul 31, 2024 | K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System B.Braun Medical, Inc. | DTK |
| Jul 26, 2024 | K241845 | Introcan Safety® 2 IV Catheter B.Braun Medical, Inc. | FOZ |
| Jul 13, 2024 | K241385 | Omnifix Syringe NRFit B.Braun Medical, Inc. | QEH |
| Sep 15, 2023 | K231242 | Perifix FX Catheter; Contiplex FX Catheter B.Braun Medical, Inc. | BSO |
| Aug 16, 2023 | K223479 | AQUAbase nX B.Braun Medical, Inc. | FIP |
| Jun 23, 2022 | K220756 | Introcan Safety 2 IV Catheter B.Braun Medical, Inc. | FOZ |
| May 14, 2022 | K220626 | Introcan Safety IV Catheter B.Braun Medical, Inc. | FOZ |
| Mar 3, 2022 | K213778 | IV Administration Set B.Braun Medical, Inc. | FPA |
| Feb 11, 2022 | K213664 | B. Braun Introcan Safety 2 IV Catheter B.Braun Medical, Inc. | FOZ |
| Jan 18, 2022 | K212842 | Microvolume Luer Access Device B.Braun Medical, Inc. | FPA |
| Oct 25, 2021 | K213085 | Introcan Safety 3 Closed IV Catheter B.Braun Medical, Inc. | FOZ |
| Sep 24, 2021 | K202618 | IV Administration Sets B.Braun Medical, Inc. | FPA |
| Dec 9, 2020 | K201469 | Mini Spike Plus 6/8R B.Braun Medical, Inc. | LHI |
| May 7, 2020 | K192577 | Actreen Hi-Lite Intermittent Urinary Catheters B.Braun Medical, Inc. | GBM |
| Apr 1, 2020 | K192676 | Introcan Safety 2 IV Catheter 18-24 gauge B.Braun Medical, Inc. | FOZ |
| Mar 19, 2020 | K191658 | IV Sets not made with PVC B.Braun Medical, Inc. | FPA |
| Mar 5, 2020 | K193101 | Omnifix Low Dead Space Luer Lock Syringe B.Braun Medical, Inc. | FMF |
| Mar 7, 2019 | K182870 | Introcan Safety 3 Closed IV Catheter B.Braun Medical, Inc. | FOZ |
| Nov 5, 2018 | K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set B.Braun Medical, Inc. | GBM |
| Aug 2, 2018 | K173531 | Lockbox for Perfusor Space PCA Infusion Pump B.Braun Medical, Inc. | MRZ |
| Jun 26, 2018 | K173361 | IV Administration Set B.Braun Medical, Inc. | FPA |
| Jun 12, 2018 | K172831 | Perfusor® Space Syringe Infusion Pump System B.Braun Medical, Inc. | FRN |
| Jun 11, 2018 | K173803 | Omnican fine B.Braun Medical, Inc. | FMI |
| Dec 22, 2017 | K171584 | B. Braun Tear-Away Introducer Needle B.Braun Medical, Inc. | BSO |
| Nov 7, 2017 | K170595 | IV Administration Sets B.Braun Medical, Inc. | FPA |
| Nov 3, 2017 | K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site B.Braun Medical, Inc. | PTI |
| May 23, 2017 | K163430 | Prontosan Wound Gel B.Braun Medical, Inc. | FRO |
| Nov 10, 2016 | K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solu B.Braun Medical, Inc. | FRO |
| Aug 12, 2016 | K153297 | Perifix and Contiplex Catheter B.Braun Medical, Inc. | BSO |
| Apr 6, 2016 | K153293 | Extension Set B.Braun Medical, Inc. | FPA |
| Feb 19, 2016 | K151423 | APEX Compounding System Transfer Set B.Braun Medical, Inc. | LHI |
| Feb 9, 2016 | K151772 | Actreen Mini Intermittent Urinary Catheters B.Braun Medical, Inc. | GBM |
| Dec 2, 2015 | K150787 | Universal Spike B.Braun Medical, Inc. | LHI |
| Nov 12, 2015 | K150800 | Valved Safety Centesis Catheter B.Braun Medical, Inc. | GCB |
| Jul 24, 2015 | K143082 | IV Administration Sets with 200(micro)m Blood Filter B.Braun Medical, Inc. | FPA |
| Jun 18, 2015 | K142596 | Infusomat Space Volumetric Infusion Pump B.Braun Medical, Inc. | FRN |
| Dec 5, 2014 | K140838 | IV ADMINISTRATION SET WITH HAND PUMP B.Braun Medical, Inc. | FPA |
| Aug 25, 2014 | K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS B.Braun Medical, Inc. | FPA |
| Jun 27, 2014 | K133632 | PERICAN ULTRA B.Braun Medical, Inc. | BSP |
| May 7, 2014 | K140311 | CARESITE LUER ACCESS DEVICE B.Braun Medical, Inc. | FPA |
| Oct 8, 2013 | K130857 | PRONTOSAN WOUND GEL X B.Braun Medical, Inc. | FRO |
| Aug 20, 2013 | K131842 | STERICAN CANNULA B.Braun Medical, Inc. | FMI |
| Nov 20, 2012 | K121846 | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE B.Braun Medical, Inc. | BSP |
| May 24, 2012 | K120150 | DUAL SPIKE TRANSFER DEVICE B.Braun Medical, Inc. | LHI |
| Jan 24, 2012 | K113059 | CONTIPLEX FX B.Braun Medical, Inc. | CAZ |
| Dec 22, 2011 | K112515 | PENCAN SPINAL NEEDLE B.Braun Medical, Inc. | BSP |
Newest 50 of 153.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2026 | B Braun Medical Inc B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. Open, Classified |
FPA | K942988 |
| Sep 2, 2026 | B Braun Medical Inc Brand Name: Extension Set
Product Name: DISCOFIX FOUR WAY STOPCOCK
Model/Catalog Number: 456025 Open, Classified |
FPA | K942988 |
| Jun 3, 2026 | B Braun Medical Inc Design Options Spinal Tray
Spinal Needle Anesthesia procedure kits:
Material Description (Material Number):
SSK H M C 20061890 (560074),
SSK S C H (560214),
SSK BJC H S (ORIGINAL CUST) (560272), Open, Classified |
OFU | None listed |
| Jun 3, 2026 | B Braun Medical Inc Spinocan Spinal Needle procedure kits:
Material Description (Material Number):
Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201);
Spinocan 25 Ga. x 3-1 Open, Classified |
OFU | None listed |
| Jun 3, 2026 | B Braun Medical Inc Spinal Needle procedure kits:
Material Description (Material Number)
24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867);
25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862);
GOVP24BK 24G PENCAN TRAY Open, Classified |
OFU | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: SESK UPMC DOUBLE CATHETER TRAY
Model/Catalog Number: 530134
Software Version: N/A
Product Description: SESK UPMC DOUBLE CATHETER TRAY
Component: No Open, Classified |
OFT | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: CESK SHANDS JACKSONVILLE 20055717
Model/Catalog Number: 555884
Software Version: N/A
Product Description: CESK SHANDS JACKSONVILLE 20055717
Component: N Open, Classified |
OGE | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: CESK RIVERSIDE HEALTH SYSTEM
Model/Catalog Number: 552126
Software Version: N/A
Product Description: CESK RIVERSIDE HEALTH SYSTEM
Component: No Open, Classified |
OGE | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID
Model/Catalog Number: 530184
Software Version: N/A
Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID
Comp Open, Classified |
OFT | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: CESK HARRIS METHODIST
Model/Catalog Number: 555498
Software Version: N/A
Product Description: CESK HARRIS METHODIST
Component: No Open, Classified |
OGE | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH
Model/Catalog Number: 530201
Software Version: N/A
Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH
Open, Classified |
OFT | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC.
Product Name: BPSK, BLOCKJOCKS TRAY
Model/Catalog Number: 570246
Software Version: N/A
Product Description: BPSK, BLOCKJOCKS TRAY
Component: No Open, Classified |
CAZ | None listed |
| May 29, 2026 | B Braun Medical Inc Brand Name: B. BRAUN MEDICAL INC
Product Name: CESK NORTHSIDE ANESTHESIA TRAY
Model/Catalog Number: 555076
Software Version: N/A
Product Description: CESK NORTHSIDE ANESTHESIA TRAY
Component: No Open, Classified |
OGE | None listed |
| Apr 15, 2026 | B Braun Medical Inc B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705. Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR.
Model Number: SL-2010M2096A. Open, Classified |
FJK | K080807 |
| Mar 2, 2026 | B Braun Medical Inc Brand Name: B. Braun
Product Name: 21GA WINGED INF SET
Model/Catalog Number: 7M2802
Software Version: N/A
Product Description: A device designed for subcutaneous implantation and intended to be used t Open, Classified |
LCJ | None listed |
| Mar 2, 2026 | B Braun Medical Inc Brand Name: B. Braun
Product Name: 21GA WINGED INFUSION, SINGLE PK
Model/Catalog Number: 7A3842
Software Version: N/A
Product Description: A device designed for subcutaneous implantation and intended Open, Classified |
LCJ | None listed |
| Mar 2, 2026 | B Braun Medical Inc Brand Name: B. Braun
Product Name: BBraun Medical 21G X4.4CM Winged INF
Model/Catalog Number: 7B3050
Software Version: N/A
Product Description: A device designed for subcutaneous implantation and inte Open, Classified |
LCJ | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K170595 K790062 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FMG | K022895 |
| Nov 26, 2025 | B Braun Medical Inc Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin Open, Classified |
FPA | K083723 K913661 +1 |
| Nov 26, 2025 | B Braun Medical Inc Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following Open, Classified |
FPA | K083723 K790062 +1 |
| Nov 26, 2025 | B Braun Medical Inc ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the follow Open, Classified |
FPA | K955585 |
| Nov 26, 2025 | B Braun Medical Inc SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followi Open, Classified |
FPA | K931377 |
| Nov 26, 2025 | B Braun Medical Inc SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin Open, Classified |
FPA | K170595 |
| Nov 26, 2025 | B Braun Medical Inc SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin Open, Classified |
FPA | K170595 |
| Nov 26, 2025 | B Braun Medical Inc RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the follow Open, Classified |
FPA | K202618 |
| Nov 26, 2025 | B Braun Medical Inc Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin Open, Classified |
FPA | K083723 K913661 |
| Nov 26, 2025 | B Braun Medical Inc Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin Open, Classified |
FMG | K060231 |
| Nov 26, 2025 | B Braun Medical Inc Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin Open, Classified |
FPA | K083723 K913661 |
| Nov 26, 2025 | B Braun Medical Inc Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin Open, Classified |
FPA | K083723 K913661 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K170595 K943770 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K790062 +1 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K790062 +1 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K170595 K931377 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K931377 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K931377 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K111016 +2 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K170595 +1 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K140311 K790062 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K111016 +1 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K111016 +1 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K790062 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K111016 +1 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K790062 +1 |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | K083723 K790062 |
Newest 50 of 510.