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)
Nov 26, 2025B Braun Medical Inc
B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following wi
Open, Classified
FPAK083723
K790062
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FPAK083723
K790062
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FPAK790062
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FPAK083723
K153293 +1
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FPAK153293
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FPAK083723
K790062 +1
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FPAK083723
K790062
Nov 26, 2025B Braun Medical Inc
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following wi
Open, Classified
FPAK954123
Nov 26, 2025B Braun Medical Inc
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following wi
Open, Classified
FPAK790062
K942988
Nov 26, 2025B Braun Medical Inc
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following wi
Open, Classified
FPAK790062
Oct 8, 2025CareFusion 303, Inc.
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve Smar
Open, Classified
FPAK022209
Sep 19, 2025Baxter Healthcare Corporation
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
Open, Classified
FPAK203609
Sep 4, 2025ICU Medical Inc.
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product C
Open, Classified
FPANone listed
Sep 4, 2025ICU Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
Open, Classified
FPANone listed
Sep 4, 2025ICU Medical Inc.
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Open, Classified
FPANone listed
Sep 4, 2025ICU Medical Inc.
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
Open, Classified
FPANone listed
Sep 4, 2025ICU Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Open, Classified
FPANone listed
Sep 4, 2025ICU Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Open, Classified
FPAK040636
Aug 6, 2025B BRAUN MEDICAL INC
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Open, Classified
FPAK902409
Jun 12, 2025BD SWITZERLAND SARL
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Open, Classified
FPANone listed
Jun 12, 2025BD SWITZERLAND SARL
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Open, Classified
FPAK053049
Jun 12, 2025BD SWITZERLAND SARL
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Ma
Open, Classified
FPAK053049
Jun 6, 2025Fresenius Kabi USA, LLC
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Open, Classified
FPAK183311
Jan 22, 2025Baxter Healthcare Corporation
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Open, Classified
FPAK203609
Jan 22, 2025Baxter Healthcare Corporation
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Open, Classified
FPAK180739
Jan 22, 2025Baxter Healthcare Corporation
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Open, Classified
FPAK180739
Jan 15, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/F
Open, Classified
FPAK852140
Oct 18, 2024Smiths Medical ASD Inc.
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Open, Classified
FPAK081156
Oct 18, 2024Smiths Medical ASD Inc.
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Open, Classified
FPAK081156
Oct 18, 2024Smiths Medical ASD Inc.
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Open, Classified
FPAK081156
Oct 18, 2024Smiths Medical ASD Inc.
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Open, Classified
FPAK081156
Oct 18, 2024Smiths Medical ASD Inc.
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Open, Classified
FPAK081156
Oct 18, 2024Smiths Medical ASD Inc.
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
Open, Classified
FPAK081156
Oct 18, 2024Smiths Medical ASD Inc.
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Open, Classified
FPAK081156
Oct 18, 2024Smiths Medical ASD Inc.
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Open, Classified
FPAK081156
Oct 18, 2024Smiths Medical ASD Inc.
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Open, Classified
FPAK081156
Sep 19, 2024Unomedical A/S
VariSoft Infusion Set, Single Use.
Open, Classified
FPAK162812
Sep 13, 2024B. Braun Medical, Inc.
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Open, Classified
FPAK022895
K111016 +1
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
Open, Classified
FPANone listed
Sep 4, 2024Fresenius Kabi USA, LLC
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Open, Classified
FPAK183311
Jul 17, 2024B. Braun Medical, Inc.
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
Open, Classified
FPAK140311
K913661
Jul 17, 2024B. Braun Medical, Inc.
Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 363230
Open, Classified
FPAK142036
Jul 17, 2024B. Braun Medical, Inc.
Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490361
Open, Classified
FPAK142036
Jul 17, 2024B. Braun Medical, Inc.
Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104
Open, Classified
FPAK142036
Jul 17, 2024B. Braun Medical, Inc.
Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103
Open, Classified
FPAK142036
Jul 17, 2024B. Braun Medical, Inc.
Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 490102
Open, Classified
FPAK142036
Jul 17, 2024B. Braun Medical, Inc.
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101
Open, Classified
FPAK142036
Jul 17, 2024B. Braun Medical, Inc.
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
Open, Classified
FPAK142036
Jul 17, 2024B. Braun Medical, Inc.
Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263
Open, Classified
FPAK142036
Jul 17, 2024B. Braun Medical, Inc.
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
Open, Classified
FPAK142036

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