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) |
|---|---|---|---|
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, 129 in Terminated |
FPA | K955585 |
| Jan 26, 2010 | B. Braun Medical, Inc. Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in Terminated |
FPA | K955585 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Safsite Inj Sites, Spin Lock Connector 134 in Terminated |
FPA | K955585 |
| Jan 26, 2010 | B. Braun Medical, Inc. Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in Terminated |
FPA | K954123 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set with Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, Spin Lock Connector 122 in Terminated |
FPA | K954123 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Safeline Injection Sites, Spin Lock Connector 120 in Terminated |
FPA | K931377 |
| Jan 26, 2010 | B. Braun Medical, Inc. Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site, 170um Blood Filter, Spin lock Connector 138 in Terminated |
FPA | K931377 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Pressure limited check Valve, Spin Lock Connector, 3 Safeline Inj Sites, 120 in Terminated |
FPA | K931377 |
| Jan 26, 2010 | B. Braun Medical, Inc. 15 Drop Universal IV Admin Set w Outlook Cassette Ultrasites and Ultraport Stopcock 132 in US1501UPHP Terminated |
FPA | K931377 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Check Valve, 5 Ultrasite Inj Sites, Ultraport HF Stopcock, 148 in US1500UPHP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Check Valve, 4 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 138 in NF1501M3HP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Ultrasite Inj Sites, B/C Valve, 2 N/C Valves Stopcock, 116 in US1500M2HP Terminated |
FPA | K931377 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 118 in NF1500M3HP Terminated |
FPA | K931377 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um Filter, Spin Lock Connector, 120 in US3112F Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Back Check Valve, Ultrasite Inj Site, Spin Lock Connector, 128 in US1506HP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike Pressure Limited Check Valve, 2 B/C Valves, 3 Ultrasite Inj Sites, 137 in US1505HP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj Sites, 3 B/C Valves, Spin Lock Connector 140 in US1504HP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 1 Safeline & 3 Ultrasite Inj Sites, Check Valve, B/C Valve 119 in US1500XHP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike & Spin Lock Connector 118 in V1500HP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Supor Membrane 1.2um Filter, Spin Lock Connector 123 in 1500FHP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set with Universal Spike and Spin Lock Connector 133 in 1500HP Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve and Pressure Limited Check Valve, 124 in US1502HP Terminated |
FPA | K955585 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check Valve, 134 in US3140 Terminated |
FPA | K955585 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasite Inj Sites, 120 in US3121M Terminated |
FPA | K955585 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/15um Filter & Inj Site, Check Valve, 2 Inj Sites, 120 in V7421M Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Safesite Inj Sites, Check Valve 120 in SS3115M Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 3 Ultrasite Inj Sites B/C Valve & Pressure Limited Check Valve 136 in US1500HP Terminated |
FPA | K955585 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Ultrasite Injection Site 0.2um Filter Ultrablock Tubing 119 in UV3169F Terminated |
FPA | K041490 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Injection Site 0.2um Filter Spin Lock Connector 115 in V7416F Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Add On Set with Ultrasite Injection Site Spin Lock Connector 88 in US3110 Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limited check valve 119 in US3169F Terminated |
FPA | K942988 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in NF3169F Terminated |
FPA | K942988 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in SS3169F Terminated |
FPA | K942988 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 0.2um Filter, Pressure limited check valve 122 in V7415F Terminated |
FPA | K942988 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve 111 in V7412F Terminated |
FPA | K942988 |
| Jan 22, 2010 | Exelint International Co. Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 26954R, 26955R, 26958R, 26959R, Terminated |
FPA | K895770 |
| Jan 22, 2010 | Exelint International Co. Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S). Terminated |
FPA | K081210 |
| Dec 9, 2009 | Baxter Healthcare Corp. Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Terminated |
FPA | K984381 |
| Jul 16, 2009 | Medtronic MiniMed Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399.
The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or M Terminated |
FPA | K011071 |
| Jun 29, 2009 | C.R. Bard, Inc., Urological Division Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA. Terminated |
FPA | K980992 |
| Jun 24, 2009 | Arrow International Inc Arrow Extension sets and accessories for intravascular use. Terminated |
FPA | K830755 |
| Jun 24, 2009 | Arrow International Inc Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits. Terminated |
FPA | K830755 |
| Jun 5, 2009 | B. Braun Medical, Inc. ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Injection Sites and Spin-Lock Connector, Catalog # V1443.
For use with Secondary Container. Terminated |
FPA | K790062 |
| Jun 5, 2009 | B. Braun Medical, Inc. Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485.
For use with Secondary Container. Terminated |
FPA | K790062 K955585 |
| Jun 5, 2009 | B. Braun Medical, Inc. Anesthesia IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites, Injection Site, Ultraport High-Flow 4-Way Stopcock with Single Valve Port and Spin-Lock Connector, Catalog # 490 Terminated |
FPA | K060231 K760383 +1 |
| Jun 5, 2009 | B. Braun Medical, Inc. Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite Injection Site and Spin-Lock Connector, Catalog #470046.
For use with the Horizon NXT Pump, and OutLook Safety I Terminated |
FPA | K904518 K955585 |
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