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) |
|---|---|---|---|
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 480254 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363433 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363430 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363424 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363423 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363422 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363421 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363420 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363030 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363010 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362432 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362431 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362420 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362050 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362034 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication.
Model/Catalog Number: 362033 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362032 Open, Classified |
FPA | K142036 |
| Jul 17, 2024 | B. Braun Medical, Inc. OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication.
Model/Catalog Number: 354213 Open, Classified |
FPA | K083723 K913661 |
| Jul 17, 2024 | B. Braun Medical, Inc. OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication.
Model/Catalog Number: 354212 Open, Classified |
FPA | K083723 K913661 |
| May 31, 2024 | BD SWITZERLAND SARL Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072
Tubing set used for delivery of fluids, medication, blood and blood products. Open, Classified |
FPA | K022209 |
| May 10, 2024 | MEDLINE INDUSTRIES, LP - Northfield Namic FLUID DELIVERY SET, REF 91300040 Open, Classified |
FPA | K852140 |
| Apr 15, 2024 | Unomedical A/S Neria Soft Infusion Set, Product Code 507302, intravascular administration set Open, Classified |
FPA | K162812 |
| Mar 14, 2024 | Baxter Healthcare Corporation CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 Open, Classified |
FPA | K180739 |
| Dec 1, 2023 | B. Braun Medical, Inc. Infusomat Administration Sets as listed below:
362031
Infusomat Space Pump Set with Caresite Injection Site;
362032
15 drops/mL, priming volume: 22mL, length: 119in, SafeLine;
362033
UNIV. 1 Open, Classified |
FPA | K142036 |
| Nov 21, 2023 | Unomedical A/S VariSoft infusion set, Model Number 1002830 Open, Classified |
FPA | K162812 |
| Nov 21, 2023 | Unomedical A/S VariSoft infusion set, Model Number 1002828 Open, Classified |
FPA | K162812 |
| Nov 21, 2023 | Unomedical A/S VariSoft infusion set, Model Number 1002827 Open, Classified |
FPA | K162812 |
| Nov 17, 2023 | Becton Dickinson & Company BD Extension Sets (Product Name, Catalog #)
BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902
BD EXTEN Open, Classified |
FPA | K022209 |
| Nov 17, 2023 | Becton Dickinson & Company BD gravity sets (Product Name, Catalog #)
32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER Open, Classified |
FPA | K022209 K882302 |
| Nov 17, 2023 | Becton Dickinson & Company BD Alaris Pump infusion sets (Product Name, Catalog #)
BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483;
BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Open, Classified |
FPA | K022209 |
| Nov 3, 2023 | B. Braun Medical, Inc. BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component. Open, Classified |
FPA | None listed |
| Nov 3, 2023 | B. Braun Medical, Inc. TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set. Open, Classified |
FPA | None listed |
| Nov 3, 2023 | B. Braun Medical, Inc. SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. Open, Classified |
FPA | K780551 |
| Nov 3, 2023 | B. Braun Medical, Inc. FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers. Open, Classified |
FPA | K780551 |
| Oct 28, 2023 | Quest Medical, Inc. Q2 Multiport Extension set, REF: 9520, Rx Only
Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needl Open, Classified |
FPA | K151079 |
| Feb 7, 2023 | Quest Medical, Inc. Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 Open, Classified |
FPA | K202672 |
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
1) REF 21-7300-24,
2) REF 21-7301-24,
3) REF 21-7302-24,
4) REF 21-7308-24,
5) REF 21-7309-24,
6) REF 21-7310-24,
7) REF 21-7322-24,
8) REF 21-7323-24,
Open, Classified |
FPA | None listed |
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
a) REF 21-7600-24,
b) REF 21-7609-24,
c) REF 21-7624-24,
d) REF 21-7649-24,
e) REF 21-7600-24JP,
f) REF 21-7609-24JP,
g) REF 21-7624-24JP,
h) REF 21-7649 Open, Classified |
FPA | K162219 |
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
a) REF 21-7308-24,
b) REF 21-7309-24,
c) REF 21-7310-24,
d) REF 21-7308-24JP,
e) REF 21-7309-24JP.
Computerized Ambulatory Delivery Device Open, Classified |
FPA | K081156 |
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
1) REF 21-7300-24,
2) REF 21-7301-24
3) REF 21-7302-24,
4) REF 21-7321-24,
5) REF 21-7322-24,
6) REF 21-7323-24,
7) REF 21-7324-24,
8) REF 21-7333-24,
9) Open, Classified |
FPA | K040636 K170982 |
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
a) REF 21-7346-24;
b) REF 21-7363-24 Open, Classified |
FPA | K031361 |
| Nov 8, 2022 | Avanos Medical, Inc. Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUC Terminated |
FPA | None listed |
| Oct 14, 2022 | B. Braun Medical, Inc. CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood. Open, Classified |
FPA | K083723 K942988 |
| Oct 14, 2022 | B. Braun Medical, Inc. Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon i Open, Classified |
FPA | K083723 K942988 +1 |
| Oct 14, 2022 | B. Braun Medical, Inc. ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets Open, Classified |
FPA | K955585 |
| Sep 26, 2022 | Unomedical A/S Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump. Terminated |
FPA | K032854 |
| Sep 14, 2022 | Baxter Healthcare Corporation Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site. Terminated |
FPA | K112893 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166 Open, Classified |
FPA | K051499 |
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