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

Company510(k)sRecalls
B.Braun Medical, Inc.23234
Baxter Healthcare Corp67151
Icu Medical, Inc.27187
Hospira, Inc.14109
Smiths Medical MD, Inc.437
Churchill Medical Systems, Inc.732
CME America, LLC038
Abbott Laboratories300
Y280
Carefusion, Inc.125
DateFirm and productCodeLinked 510(k)
Mar 15, 2021B. Braun Medical, Inc.
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermi
Terminated		 FPAK153293
K942988
Dec 21, 2020Baxter Healthcare Corporation
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient u
Terminated		 FPAK132734
Aug 31, 2020ICU Medical, Inc.
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034
Open, Classified		 FPANone listed
Aug 31, 2020ICU Medical, Inc.
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46
Open, Classified		 FPANone listed
Aug 31, 2020ICU Medical, Inc.
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
Open, Classified		 FPAK941190
Aug 31, 2020ICU Medical, Inc.
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Lu
Open, Classified		 FPAK082806
Aug 31, 2020ICU Medical, Inc.
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml,
Open, Classified		 FPAK081361
Aug 31, 2020ICU Medical, Inc.
Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35"
Open, Classified		 FPANone listed
Aug 31, 2020ICU Medical, Inc.
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (
Open, Classified		 FPAK070532
Jul 15, 2020CME America, LLC
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset With Female Luer, REF: A120-160XPSN
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Set, REF: A120-160C
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
Standard BodySet with Needleless Connectors, REF: A120-125XS
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard set with Female Luer, REF: A120-003XSN
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Sets, REF: A120-161C
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Sets, REF: A120-160C2YRV
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Sets, REF: A120-160CYFRV
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160GCFA
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-125XSE
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-003XS2YV
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XSL
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XE90S
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Filter, REF: A100-164XESF
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Filter, REF: A120-160XSFE
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Set, REF: A120-161CYF
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Set, REF: A120-160CRV
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160X2YB
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-161XPSV
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Filter, REF: A100-163XESF
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-161XYBS
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-161XYB
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160XYSF
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XSFL
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-112XSFK
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160XSFK
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-161XPS
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XES
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XESV
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160XPS
Terminated		 FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard BodySet, REF: A120-160SAS
Terminated		 FPAK042696
Jul 14, 2020Smiths Medical ASD Inc.
CADD Administration Sets, Model #21-7346-24
Terminated		 FPAK031361
Jul 6, 2020ICU Medical, Inc.
SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)4476418. Administration sets and their accessories are single use, pre-sterilized de
Terminated		 FPANone listed
Jul 6, 2020ICU Medical, Inc.
10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709083346(17)250201(30)50(10)4718652. The Intravascular Administ
Terminated		 FPANone listed
Jul 6, 2020ICU Medical, Inc.
5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709077758(17)250101(30)50(10)4603285;(01)10887709077758(17)2501
Terminated		 FPANone listed

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