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)
Jan 14, 2020CME America, LLC
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA the
Terminated
FPAK031749
Dec 12, 2019Baxter Healthcare Corporation
ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended
Open, Classified
FPAK961225
Dec 12, 2019Baxter Healthcare Corporation
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through
Open, Classified
FPAK961225
Nov 20, 2019B. Braun Medical, Inc.
Safeline Y-Type Blood Set, Catalog Number V2500
Terminated
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Safeline Y-Type Blood Set, Catalog Number NF5140
Terminated
FPAK840212
K931377
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490530
Terminated
FPAK060231
K140311 +1
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490425
Terminated
FPAK022895
K083723 +1
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490314
Terminated
FPAK060231
K083723 +3
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490293
Terminated
FPAK022895
K083723 +1
Nov 20, 2019B. Braun Medical, Inc.
Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Terminated
FPAK140311
K922637
Oct 4, 2019ICU Medical, Inc.
REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
Terminated
FPAK100576
Sep 23, 2019B. Braun Medical, Inc.
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Terminated
FPAK142036
Aug 20, 2019Repro-Med Systems, Inc.
20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the
Terminated
FPAK122404
Jul 11, 2019Becton Dickinson & Company
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-00
Terminated
FPAK894842
Jul 8, 2019Smiths Medical ASD Inc.
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.2
Terminated
FPAK870866
Jun 26, 2019Becton Dickinson & Company
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Terminated
FPAK811885
Jun 10, 2019Molded Products Inc
Luer Lock Set - Catalog # MPC-125, for IV administration sets.
Terminated
FPAK925927
May 29, 2019Zyno Medical LLC
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
Terminated
FPAK132841
May 29, 2019Zyno Medical LLC
Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
Terminated
FPAK132841
May 2, 2019Becton Dickinson & Company
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
Terminated
FPAK083472
Apr 15, 2019ICU Medical, Inc.
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer
Terminated
FPANone listed
Apr 15, 2019ICU Medical, Inc.
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents t
Terminated
FPANone listed
Apr 15, 2019ICU Medical, Inc.
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental con
Terminated
FPAK131549
Apr 15, 2019ICU Medical, Inc.
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV
Terminated
FPANone listed
Apr 15, 2019ICU Medical, Inc.
icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV admini
Terminated
FPANone listed
Apr 15, 2019ICU Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the trans
Terminated
FPAK081361
Apr 15, 2019ICU Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the tran
Terminated
FPAK081361
Apr 10, 2019Becton Dickinson & Company
MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ80
Terminated
FPAK171957
Mar 5, 2019Becton Dickinson & Company
Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
Terminated
FPAK931173
Mar 5, 2019Becton Dickinson & Company
Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
Terminated
FPAK931173
Dec 6, 2018Vygon U.S.A.
Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
Terminated
FPANone listed
Dec 6, 2018Vygon U.S.A.
Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
Terminated
FPANone listed
Sep 26, 2018Becton Dickinson & Company
PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for g
Terminated
FPAK811885
Sep 26, 2018Becton Dickinson & Company
PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for grav
Terminated
FPAK811885
Sep 7, 2018Bayer Medical Care, Inc.
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration
Terminated
FPAK830755
Jul 5, 2018Medtronic Inc.
Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
Terminated
FPANone listed
May 9, 2018B. Braun Medical, Inc.
Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Va
Terminated
FPAK142036
Apr 20, 2018CareFusion 303, Inc.
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP
Terminated
FPAK894842
Jan 5, 2018Repro-Med Systems, Inc.
HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS6
Terminated
FPAK122404
Nov 10, 2017Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve include
Terminated
FPAK981816
Nov 10, 2017Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Prot
Terminated
FPAK981816
Nov 10, 2017Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curl
Terminated
FPAK981816
Nov 10, 2017Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumet
Terminated
FPAK981816
Nov 10, 2017Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Cur
Terminated
FPAK981816
Nov 10, 2017Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Steri
Terminated
FPAK981816
Nov 6, 2017CareFusion 303, Inc.
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's a
Terminated
FPAK790108
K790582
Sep 10, 2017Medtronic Inc.
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
Open, Classified
FPAK160648
Sep 10, 2017Medtronic Inc.
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
Open, Classified
FPAK160648
Sep 10, 2017Medtronic Inc.
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
Open, Classified
FPAK160648
Sep 10, 2017Medtronic Inc.
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
Open, Classified
FPAK160648

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