FDA Product Code
FDA Product Code FPA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 1,175 records · page 2 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161036 | Hospira Extension Set, Hospira Primary Set | Hospira, Inc. | 2017-01-06 | Traditional | PDF ↗ |
| K160007 | Paclitaxel Sets | Baxter Healthcare Corporation | 2016-12-19 | Traditional | PDF ↗ |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets | Quest Medical, Inc. | 2016-12-06 | Traditional | PDF ↗ |
| K161323 | Solution Set for Epidural Use | Baxter Healthcare Corporation | 2016-11-30 | Traditional | PDF ↗ |
| K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device) | 410 Medical Innovation, LLC | 2016-08-25 | Traditional | PDF ↗ |
| K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set | C.R. Bard, Inc. | 2016-08-18 | Traditional | PDF ↗ |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | Unomedical A/S | 2016-08-10 | Traditional | PDF ↗ |
| K151250 | Smart Set | Top Spins, Inc. | 2016-06-07 | Abbreviated | PDF ↗ |
| K160870 | Hospira Administration Sets | Hospira, Inc. | 2016-06-01 | Special | PDF ↗ |
| K150921 | Orbit Infusion Set | Ypsomed AG | 2016-04-12 | Traditional | PDF ↗ |
| K160651 | BD FlowSmart Set, MiniMed Pro-Set | Becton, Dickinson and Company | 2016-04-07 | Special | PDF ↗ |
| K153293 | Extension Set | B.Braun Medical, Inc. | 2016-04-06 | Traditional | PDF ↗ |
| K151969 | Hospira Extension Sets | Icu Medical, Inc. | 2016-01-19 | Traditional | PDF ↗ |
| K153158 | Solution Administration Sets with 0.2 Micron Filter | Baxter Healthcare Corporation | 2015-12-28 | Special | PDF ↗ |
| K153257 | BD FlowSmart Set, MiniMed Pro-Set | Becton, Dickinson and Company | 2015-12-11 | Special | PDF ↗ |
| K151079 | Q2 Intravenous Adminstration Sets and Extension Sets | Quest Medical, Inc. | 2015-09-30 | Traditional | PDF ↗ |
| K151151 | U & U Intravascular Administration Set | U&U Medical Technology Co, Ltd. | 2015-09-24 | Traditional | PDF ↗ |
| K143446 | Accu-Chek FlexLink Plus infusion set | Roche Diagnostics GmbH | 2015-08-13 | Traditional | PDF ↗ |
| K143082 | IV Administration Sets with 200(micro)m Blood Filter | B.Braun Medical, Inc. | 2015-07-24 | Traditional | PDF ↗ |
| K150513 | Imed Technology Intravascular Administration Set, Imed Technology Extension Set | Imed Technology, Inc. | 2015-05-28 | Abbreviated | PDF ↗ |
| K150059 | BD FlowSmart Set | Becton, Dickinson Company | 2015-04-28 | Traditional | PDF ↗ |
| K150860 | Nitroglycerin Sets with DUO-VENT Spike | Baxter Healthcare Corporation | 2015-04-16 | Traditional | PDF ↗ |
| K143087 | Hospira Blood Set | Hospira, Inc. | 2015-03-04 | Traditional | PDF ↗ |
| K143015 | Hospira Primary Sets | Hospira, Inc. | 2015-02-25 | Traditional | PDF ↗ |
| K141285 | BUSSE EXTENSION SET | Busse Hospital Disposables | 2015-02-19 | Traditional | PDF ↗ |
| K142590 | All Safe Huber Safety Infusion Set | Nexus Medical, LLC | 2015-01-16 | Traditional | PDF ↗ |
| K142622 | IV Administration | Hospira, Inc. | 2015-01-15 | Traditional | PDF ↗ |
| K142974 | Extension Sets | Hospira, Inc. | 2015-01-09 | Traditional | PDF ↗ |
| K142433 | Hospira Extension Set | Hospira, Inc. | 2014-12-08 | Traditional | PDF ↗ |
| K140838 | IV ADMINISTRATION SET WITH HAND PUMP | B.Braun Medical, Inc. | 2014-12-05 | Traditional | PDF ↗ |
| K142367 | Hospira Primary Sets | Hospira, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K143234 | MaxZero Administration Sets | Care Fusion | 2014-11-20 | Traditional | PDF ↗ |
| K141200 | PADI-LOCK | Padi-Lock, LLC | 2014-10-02 | Traditional | PDF ↗ |
| K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | Acacia, Inc. | 2014-09-19 | Traditional | PDF ↗ |
| K142097 | SELEC-3 I.V.ADMINISTRATION SET | Biomedix, Inc. | 2014-08-29 | Special | PDF ↗ |
| K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS | B.Braun Medical, Inc. | 2014-08-25 | Special | PDF ↗ |
| K142011 | SOLUTION SET/EXTENSION SET | Baxter Healthcare Corporation | 2014-08-18 | Special | PDF ↗ |
| K141834 | SAPPHIRE ADMINISTRATION SET | Q Core Medical , Ltd. | 2014-08-05 | Special | PDF ↗ |
| K140175 | INTRAVASCULAR ADMINISTRATION SET | Delta Med Spa | 2014-08-05 | Traditional | PDF ↗ |
| K141306 | TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE | Teva Medical Ltd., Migada Plant | 2014-06-12 | Special | PDF ↗ |
| K133351 | NEXUS NIS-6P LUER ACTIVATED DEVICE | Nexus Medical, LLC | 2014-05-22 | Traditional | PDF ↗ |
| K140133 | INFUSET FLOW CONTROL EXTENSION SET | Emed Technologies Corporation | 2014-05-15 | Traditional | PDF ↗ |
| K140311 | CARESITE LUER ACCESS DEVICE | B.Braun Medical, Inc. | 2014-05-07 | Traditional | PDF ↗ |
| K140831 | MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR | Care Fusion | 2014-04-15 | Traditional | PDF ↗ |
| K140131 | SUB-Q SUBCUTANEOUS TISSUE INFUSION SET | Emed Technologies Corporation | 2014-04-03 | Special | PDF ↗ |
| K133073 | CAIR DRIVE, NEUTRACLEAR | Cair Lgl | 2014-03-20 | Traditional | PDF ↗ |
| K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) | Terumo Europe N.V. | 2014-03-18 | Traditional | PDF ↗ |
| K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | Terumo Europe N.V. | 2014-02-05 | Special | PDF ↗ |
| K132841 | ZYNO MEDICAL ADMINISTRATION SET | Zyno Medical, LLC | 2014-01-23 | Special | PDF ↗ |
| K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE | Medical Components, Inc. | 2014-01-08 | Traditional | PDF ↗ |
| K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | Baxter Healthcare Corp | 2013-10-08 | Special | PDF ↗ |
| K132142 | NERIA SOFT 90 INFUSION SET | Unomedical A/S | 2013-10-08 | Traditional | PDF ↗ |
| K132413 | MZ1000 | Care Fusion | 2013-08-29 | Traditional | PDF ↗ |
| K130879 | NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS | Nexus Medical, LLC | 2013-07-09 | Traditional | PDF ↗ |
| K130416 | NEXUS TKO-6P LUER ACTIVATED DEVICE | Nexus Medical, LLC | 2013-06-12 | Traditional | PDF ↗ |
| K122404 | MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 | Repro-Med Systems, Inc. Dba Rms Medical Products | 2013-05-06 | Traditional | PDF ↗ |
| K130023 | K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR | Np Medical, Inc. | 2013-04-03 | Traditional | PDF ↗ |
| K130468 | ORBIT INFUSION SET | Ypsomed AG | 2013-03-19 | Special | PDF ↗ |
| K123344 | K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) | Kawasumi Laboratories, Inc. | 2013-03-07 | Traditional | PDF ↗ |
| K121511 | MACLIN POWER INTRAVASCULAR ADMINISTRATION SET | Maclin Power, Inc. | 2013-03-07 | Traditional | PDF ↗ |
| K121269 | TBA | Migada Plant | 2013-01-22 | Traditional | PDF ↗ |
| K123874 | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S | Baxter Healthcare Corp | 2013-01-10 | Special | PDF ↗ |
| K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | Baxter Healthcare Corp | 2013-01-08 | Special | PDF ↗ |
| K123729 | VERSARATE FLOW RATE CONTROLER | Emed Technologies Corporation | 2012-12-21 | Traditional | PDF ↗ |
| K121803 | INTRAVASCULAR ADMINISTRATION SET | Acta Medical, LLC | 2012-12-19 | Abbreviated | PDF ↗ |
| K122686 | ACCU-CHEK ULTRAFLEX INFUSION SET | Roche Diabetes Care AG | 2012-11-16 | Special | PDF ↗ |
| K113471 | NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET | Nipro Medical Corporation | 2012-10-18 | Traditional | PDF ↗ |
| K113470 | NIPRO SAFE TOUCH HUBER INFUSION SET | Nipro Medical Corporation | 2012-10-17 | Traditional | PDF ↗ |
| K120685 | ZYNO MEDICAL ADMINISTRATION SET | Zyno Medical, LLC | 2012-09-07 | Abbreviated | PDF ↗ |
| K120195 | SAFETY SUBCUTANEOUS TISSUE INFUSION SET | Multi Med | 2012-07-06 | Traditional | PDF ↗ |
| K121634 | INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR | Baxter Healthcare Corporation | 2012-06-29 | Special | PDF ↗ |
| K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET | Baxter Healthcare Corp | 2012-06-29 | Traditional | PDF ↗ |
| K120375 | MED-RX PATIENT DELIVERY SET | Benlan, Inc. | 2012-06-28 | Traditional | PDF ↗ |
| K121032 | PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP | Hospira, Inc. | 2012-06-21 | Special | PDF ↗ |
| K121554 | Q-FLO CLOSED MALE LUER CONNECTOR | Us Fusion, LLC. Dba Truecare Biomedix-USA | 2012-06-08 | Traditional | PDF ↗ |
| K120395 | NERIA MULTI SUBCUTANEOUS INFUSION SET | Unomedical Devices S.A DE C.V. | 2012-05-30 | Traditional | PDF ↗ |
| K120443 | NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE | Baxter Healthcare Corporation - Renal Division | 2012-05-22 | Traditional | PDF ↗ |
| K120548 | HLIC NEEDLE-LESS VALVE | Health Line International Corporation | 2012-05-04 | Traditional | PDF ↗ |
| K120261 | PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER | Perouse Medical | 2012-05-02 | Traditional | PDF ↗ |
| K120872 | ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS | Unomedical A/S Infusion Devices | 2012-04-20 | Special | PDF ↗ |
| K113398 | NEXUS TKO-6, LUER-ACTIVATED DEVICE | Nexus Medical, LLC | 2012-04-18 | Traditional | PDF ↗ |
| K112073 | INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... | Rx Devices, LLC | 2012-04-11 | Traditional | PDF ↗ |
| K120799 | ARISURE NEUTRAL VALVE | Yukon Medical, LLC | 2012-03-30 | Traditional | PDF ↗ |
| K113683 | LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL | Hospira, Inc. | 2012-01-12 | Special | PDF ↗ |
| K112799 | MED-RX EXTENSION SET WITH T-CONNECTOR | Benlan, Inc. | 2011-12-23 | Traditional | PDF ↗ |
| K112636 | CYTOGUARD(TM) CLOSED LUER CONNECTOR | B.Braun Medical, Inc. | 2011-11-26 | Traditional | PDF ↗ |
| K112512 | VANISHPOINT BLOOD COLLECTION SET | Retractable Technologies, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | Baxter Healthcare Corporation | 2011-10-18 | Special | PDF ↗ |
| K111351 | TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET | Us Infusion Dba Truecare Biomedix | 2011-09-29 | Abbreviated | PDF ↗ |
| K102405 | INFUSION SET FOR POWERPICC SOLO 2 CATHETER | C.R. Bard, Inc. | 2011-07-21 | Traditional | PDF ↗ |
| K103562 | CENTURION PRESSURE INJECTABLE EXTENSION SET | Centurion Medical Products Corporation | 2011-06-23 | Abbreviated | PDF ↗ |
| K111016 | SAFEPORT MANIFOLD (TM) (OR STOPCOCK) | Elcam Medical Acal | 2011-06-09 | Special | PDF ↗ |
| K102512 | RMS SUBCUTANEOUS NEEDLE SET | Repro-Med Systems, Inc. | 2011-05-20 | Traditional | PDF ↗ |
| K110282 | LIGHTY DD INFUSION SET | Medx-Set, Ltd. | 2011-04-27 | Traditional | PDF ↗ |
| K103551 | INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, | Baxter Healthcare Corp | 2011-03-25 | Traditional | PDF ↗ |
| K103224 | HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING | Hospira, Inc. | 2011-01-07 | Special | PDF ↗ |
| K100576 | HIGH PRESSURE SETS-400 PSI | Icu Medical, Inc. | 2010-12-17 | Traditional | PDF ↗ |
| K103344 | INFUSION SETS | Hospira, Inc. | 2010-12-10 | Special | PDF ↗ |
| K100720 | K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING | Kawasumi Laboratories, Inc. | 2010-11-18 | Traditional | PDF ↗ |
| K101368 | D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES | Dragon Heart Medical, Inc. | 2010-11-18 | Abbreviated | PDF ↗ |
Product code FPA · Class II · General Hospital. Data: openFDA.