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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 2017 | K161898 | Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set Beijing Fert Technology Co., Ltd., CN | FPA |
| Jan 6, 2017 | K161036 | Hospira Extension Set, Hospira Primary Set Hospira, Inc. | FPA |
| Dec 19, 2016 | K160007 | Paclitaxel Sets Baxter Healthcare Corporation | FPA |
| Dec 6, 2016 | K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets Quest Medical, Inc. | FPA |
| Nov 30, 2016 | K161323 | Solution Set for Epidural Use Baxter Healthcare Corporation | FPA |
| Aug 25, 2016 | K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device) 410 Medical Innovation, LLC | FPA |
| Aug 18, 2016 | K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set C.R. Bard, Inc. | FPA |
| Aug 10, 2016 | K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® Unomedical A/S, DK | FPA |
| Jun 7, 2016 | K151250 | Smart Set Top Spins, Inc. | FPA |
| Jun 1, 2016 | K160870 | Hospira Administration Sets Hospira, Inc. | FPA |
| Apr 12, 2016 | K150921 | Orbit Infusion Set Ypsomed AG, CH | FPA |
| Apr 7, 2016 | K160651 | BD FlowSmart Set, MiniMed Pro-Set Becton, Dickinson and Company | FPA |
| Apr 6, 2016 | K153293 | Extension Set B.Braun Medical, Inc. | FPA |
| Jan 19, 2016 | K151969 | Hospira Extension Sets Icu Medical, Inc. | FPA |
| Dec 28, 2015 | K153158 | Solution Administration Sets with 0.2 Micron Filter Baxter Healthcare Corporation | FPA |
| Dec 11, 2015 | K153257 | BD FlowSmart Set, MiniMed Pro-Set Becton, Dickinson and Company | FPA |
| Sep 30, 2015 | K151079 | Q2 Intravenous Adminstration Sets and Extension Sets Quest Medical, Inc. | FPA |
| Sep 24, 2015 | K151151 | U & U Intravascular Administration Set U&U Medical Technology Co, Ltd., CN | FPA |
| Aug 13, 2015 | K143446 | Accu-Chek FlexLink Plus infusion set Roche Diagnostics GmbH, DE | FPA |
| Jul 24, 2015 | K143082 | IV Administration Sets with 200(micro)m Blood Filter B.Braun Medical, Inc. | FPA |
| May 28, 2015 | K150513 | Imed Technology Intravascular Administration Set, Imed Technology Extension Set Imed Technology, Inc. | FPA |
| Apr 28, 2015 | K150059 | BD FlowSmart Set Becton, Dickinson Company | FPA |
| Apr 16, 2015 | K150860 | Nitroglycerin Sets with DUO-VENT Spike Baxter Healthcare Corporation | FPA |
| Mar 4, 2015 | K143087 | Hospira Blood Set Hospira, Inc. | FPA |
| Feb 25, 2015 | K143015 | Hospira Primary Sets Hospira, Inc. | FPA |
| Feb 19, 2015 | K141285 | BUSSE EXTENSION SET Busse Hospital Disposables | FPA |
| Jan 16, 2015 | K142590 | All Safe Huber Safety Infusion Set Nexus Medical, LLC | FPA |
| Jan 15, 2015 | K142622 | IV Administration Hospira, Inc. | FPA |
| Jan 9, 2015 | K142974 | Extension Sets Hospira, Inc. | FPA |
| Dec 8, 2014 | K142433 | Hospira Extension Set Hospira, Inc. | FPA |
| Dec 5, 2014 | K140838 | IV ADMINISTRATION SET WITH HAND PUMP B.Braun Medical, Inc. | FPA |
| Nov 25, 2014 | K142367 | Hospira Primary Sets Hospira, Inc. | FPA |
| Nov 20, 2014 | K143234 | MaxZero Administration Sets Care Fusion | FPA |
| Oct 2, 2014 | K141200 | PADI-LOCK Padi-Lock, LLC | FPA |
| Sep 19, 2014 | K142527 | Extension Set with BD Q-Syte Luer Access Split Septum Acacia, Inc. | FPA |
| Aug 29, 2014 | K142097 | SELEC-3 I.V.ADMINISTRATION SET Biomedix, Inc. | FPA |
| Aug 25, 2014 | K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS B.Braun Medical, Inc. | FPA |
| Aug 18, 2014 | K142011 | SOLUTION SET/EXTENSION SET Baxter Healthcare Corporation | FPA |
| Aug 5, 2014 | K141834 | SAPPHIRE ADMINISTRATION SET Q Core Medical , Ltd. | FPA |
| Aug 5, 2014 | K140175 | INTRAVASCULAR ADMINISTRATION SET Delta Med Spa, IT | FPA |
| Jun 12, 2014 | K141306 | TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE Teva Medical Ltd., Migada Plant, IT | FPA |
| May 22, 2014 | K133351 | NEXUS NIS-6P LUER ACTIVATED DEVICE Nexus Medical, LLC | FPA |
| May 15, 2014 | K140133 | INFUSET FLOW CONTROL EXTENSION SET Emed Technologies Corporation | FPA |
| May 7, 2014 | K140311 | CARESITE LUER ACCESS DEVICE B.Braun Medical, Inc. | FPA |
| Apr 15, 2014 | K140831 | MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR Care Fusion | FPA |
| Apr 3, 2014 | K140131 | SUB-Q SUBCUTANEOUS TISSUE INFUSION SET Emed Technologies Corporation | FPA |
| Mar 20, 2014 | K133073 | CAIR DRIVE, NEUTRACLEAR Cair Lgl | FPA |
| Mar 18, 2014 | K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., BE | FPA |
| Feb 5, 2014 | K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., BE | FPA |
| Jan 23, 2014 | K132841 | ZYNO MEDICAL ADMINISTRATION SET Zyno Medical, LLC | FPA |
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