Panels › General Hospital › Product code FPA · Class 2
Set, Administration, Intravascular
Regulation 880.5440
6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc B.BRAUN 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 wi Open, Classified |
FPA | K083723 K790062 |
| Nov 26, 2025 | B Braun Medical Inc Anesthesia IV 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 fo Open, Classified |
FPA | K083723 K790062 |
| Nov 26, 2025 | B Braun Medical Inc Anesthesia IV 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 fo Open, Classified |
FPA | K790062 |
| Nov 26, 2025 | B Braun Medical Inc Anesthesia IV 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 fo Open, Classified |
FPA | K083723 K153293 +1 |
| Nov 26, 2025 | B Braun Medical Inc Anesthesia IV 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 fo Open, Classified |
FPA | K153293 |
| Nov 26, 2025 | B Braun Medical Inc Anesthesia IV 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 fo Open, Classified |
FPA | K083723 K790062 +1 |
| Nov 26, 2025 | B Braun Medical Inc Anesthesia IV 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 fo Open, Classified |
FPA | K083723 K790062 |
| Nov 26, 2025 | B Braun Medical Inc ADDitIV 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 wi Open, Classified |
FPA | K954123 |
| Nov 26, 2025 | B Braun Medical Inc ADDitIV 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 wi Open, Classified |
FPA | K790062 K942988 |
| Nov 26, 2025 | B Braun Medical Inc ADDitIV 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 wi Open, Classified |
FPA | K790062 |
| Oct 8, 2025 | CareFusion 303, Inc. BD Alaris Pump Infusion Sets for the following reference numbers:
C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site
10015414, 180 Micron Filter
2447-0007, Ball Valve Smar Open, Classified |
FPA | K022209 |
| Sep 19, 2025 | Baxter Healthcare Corporation Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set Open, Classified |
FPA | K203609 |
| Sep 4, 2025 | ICU Medical Inc. Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product C Open, Classified |
FPA | None listed |
| Sep 4, 2025 | ICU Medical Inc. Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24 Open, Classified |
FPA | None listed |
| Sep 4, 2025 | ICU Medical Inc. Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24 Open, Classified |
FPA | None listed |
| Sep 4, 2025 | ICU Medical Inc. Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24 Open, Classified |
FPA | None listed |
| Sep 4, 2025 | ICU Medical Inc. Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24 Open, Classified |
FPA | None listed |
| Sep 4, 2025 | ICU Medical Inc. Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24 Open, Classified |
FPA | K040636 |
| Aug 6, 2025 | B BRAUN MEDICAL INC Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. Open, Classified |
FPA | K902409 |
| Jun 12, 2025 | BD SWITZERLAND SARL BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241;
BD TEXIUM (China), REF: 10012241 CHINA Open, Classified |
FPA | None listed |
| Jun 12, 2025 | BD SWITZERLAND SARL BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 Open, Classified |
FPA | K053049 |
| Jun 12, 2025 | BD SWITZERLAND SARL Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T;
SmartSite Bag Access Non-Vented Bonded Texium Closed Ma Open, Classified |
FPA | K053049 |
| Jun 6, 2025 | Fresenius Kabi USA, LLC IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set. Open, Classified |
FPA | K183311 |
| Jan 22, 2025 | Baxter Healthcare Corporation Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 Open, Classified |
FPA | K203609 |
| Jan 22, 2025 | Baxter Healthcare Corporation Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 Open, Classified |
FPA | K180739 |
| Jan 22, 2025 | Baxter Healthcare Corporation Baxter Solution Set with Duo-Vent Spike, REF 2R8404 Open, Classified |
FPA | K180739 |
| Jan 15, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Fluid Delivery Set with Drip Chamber:
1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069;
2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222;
3) FDS,135,NV,MICRO-CHAMBER,W/F Open, Classified |
FPA | K852140 |
| Oct 18, 2024 | Smiths Medical ASD Inc. ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 Open, Classified |
FPA | K081156 |
| Oct 18, 2024 | Smiths Medical ASD Inc. ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28 Open, Classified |
FPA | K081156 |
| Oct 18, 2024 | Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP Open, Classified |
FPA | K081156 |
| Oct 18, 2024 | Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP Open, Classified |
FPA | K081156 |
| Oct 18, 2024 | Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Open, Classified |
FPA | K081156 |
| Oct 18, 2024 | Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 Open, Classified |
FPA | K081156 |
| Oct 18, 2024 | Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 Open, Classified |
FPA | K081156 |
| Oct 18, 2024 | Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 Open, Classified |
FPA | K081156 |
| Oct 18, 2024 | Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Open, Classified |
FPA | K081156 |
| Sep 19, 2024 | Unomedical A/S VariSoft Infusion Set, Single Use. Open, Classified |
FPA | K162812 |
| Sep 13, 2024 | B. Braun Medical, Inc. AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036 Open, Classified |
FPA | K022895 K111016 +1 |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
ADMIT KIT PILLOW BOX, Pack Number DYKA1389 Open, Classified |
FPA | None listed |
| Sep 4, 2024 | Fresenius Kabi USA, LLC LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion. Open, Classified |
FPA | K183311 |
| Jul 17, 2024 | B. Braun Medical, Inc. OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490564 Open, Classified |
FPA | K140311 K913661 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 363230 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490361 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number : 490104 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490103 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number 490102 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490101 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490100 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number 480263 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 480255 Open, Classified |
FPA | K142036 |
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