ClearanceBrief
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)
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Top companies in FPA

DateFirm and productCodeLinked 510(k)
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK142036
Jul 17, 2024B. 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
FPAK083723
K913661
Jul 17, 2024B. 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
FPAK083723
K913661
May 31, 2024BD 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
FPAK022209
May 10, 2024MEDLINE INDUSTRIES, LP - Northfield
Namic FLUID DELIVERY SET, REF 91300040
Open, Classified
FPAK852140
Apr 15, 2024Unomedical A/S
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Open, Classified
FPAK162812
Mar 14, 2024Baxter Healthcare Corporation
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Open, Classified
FPAK180739
Dec 1, 2023B. 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
FPAK142036
Nov 21, 2023Unomedical A/S
VariSoft infusion set, Model Number 1002830
Open, Classified
FPAK162812
Nov 21, 2023Unomedical A/S
VariSoft infusion set, Model Number 1002828
Open, Classified
FPAK162812
Nov 21, 2023Unomedical A/S
VariSoft infusion set, Model Number 1002827
Open, Classified
FPAK162812
Nov 17, 2023Becton 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
FPAK022209
Nov 17, 2023Becton 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
FPAK022209
K882302
Nov 17, 2023Becton 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
FPAK022209
Nov 3, 2023B. Braun Medical, Inc.
BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
Open, Classified
FPANone listed
Nov 3, 2023B. Braun Medical, Inc.
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
Open, Classified
FPANone listed
Nov 3, 2023B. Braun Medical, Inc.
SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
Open, Classified
FPAK780551
Nov 3, 2023B. Braun Medical, Inc.
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
Open, Classified
FPAK780551
Oct 28, 2023Quest 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
FPAK151079
Feb 7, 2023Quest Medical, Inc.
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Open, Classified
FPAK202672
Jan 30, 2023Smiths 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
FPANone listed
Jan 30, 2023Smiths 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
FPAK162219
Jan 30, 2023Smiths 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
FPAK081156
Jan 30, 2023Smiths 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
FPAK040636
K170982
Jan 30, 2023Smiths Medical ASD Inc.
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Open, Classified
FPAK031361
Nov 8, 2022Avanos 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
FPANone listed
Oct 14, 2022B. 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
FPAK083723
K942988
Oct 14, 2022B. 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
FPAK083723
K942988 +1
Oct 14, 2022B. 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
FPAK955585
Sep 26, 2022Unomedical 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
FPAK032854
Sep 14, 2022Baxter Healthcare Corporation
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Terminated
FPAK112893
Sep 13, 2022CAREFUSION
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Open, Classified
FPAK051499

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