Panels › General Hospital › Product code FPA · Class 2
Set, Administration, Intravascular
Regulation 880.5440
5510(k)s in 12 months (1,175 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. | 22 | 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) |
|---|---|---|---|
| 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 15, 2026 | BD SWITZERLAND SARL BD Alaris Pump Infusion Sets
10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites
10015861A 10885403232626 50885403232624 BD Ala Open, Classified |
FPA | K022209 |
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FPA | K081361 K100576 +3 |
| Sep 11, 2026 | ICU Medical, Inc. Oncology sets with drip chambers Open, Classified |
FPA | K081361 |
| Sep 11, 2026 | ICU Medical, Inc. Plum administration sets Open, Classified |
FPA | None listed |
| 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 |
| Aug 13, 2026 | BD SWITZERLAND SARL 60 In Non-DEHP Minibore Extension Set RES ME2010
UDI-DI code: 10885403236235
MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C
UDI-DI code: 10885403274619
9 IN Extension Set w/Max Y REF MPX5300- Open, Classified |
FPA | K051499 K083472 |
| Aug 11, 2026 | Baxter Healthcare Corporation Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets Open, Classified |
FPA | K243529 |
| Jul 2, 2026 | BD SWITZERLAND SARL MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555
Catalog Number: SAM2461
UDI code: N/A
Engineering Sample/Not for Human Use Open, Classified |
FPA | None listed |
| Jul 1, 2026 | Medela Inc Brand Name: Medela
Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN
Model/Catalog Number: ENF060182LD / 101033086
Software Version: N/A
Product Description: Enteral Extension Set, Length 60 Orange- Open, Classified |
FPA | K895367 |
| Apr 6, 2026 | Molded Products Inc See Luer Cap Set, MPC-130, set, administration, intravascular Open, Classified |
FPA | K925927 |
| Feb 13, 2026 | Medline Industries, LP Medline Industries IV Administration and Extension Sets:
1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529;
2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029;
3) DBD-IVEX Open, Classified |
FPA | K242126 |
| Jan 16, 2026 | ICU Medical, Inc. Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 Open, Classified |
FPA | K053106 |
| 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 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 |
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 |
| 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 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 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 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 | K140311 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 |
| 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 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 | 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 | 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 | K170595 K931377 |
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