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) |
|---|---|---|---|
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set, REF: ME1069 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 Open, Classified |
FPA | K051499 |
| Aug 1, 2022 | ICU Medical, Inc. 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer; Open, Classified |
FPA | None listed |
| Aug 1, 2022 | ICU Medical, Inc. 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP.
Accessory for intravascular administration set. Open, Classified |
FPA | K082806 |
| Aug 1, 2022 | ICU Medical, Inc. 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer; Open, Classified |
FPA | K100576 |
| Aug 1, 2022 | ICU Medical, Inc. MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery. Open, Classified |
FPA | K100434 |
| Oct 28, 2021 | Stradis Medical, LLC dba Stradis Healthcare Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk Terminated |
FPA | K993463 |
| Aug 10, 2021 | B. Braun Medical, Inc. Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: NF3120 Terminated |
FPA | K922637 K931377 |
| Aug 10, 2021 | B. Braun Medical, Inc. Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Terminated |
FPA | K922637 K931377 |
| Aug 10, 2021 | B. Braun Medical, Inc. Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: V7400 Terminated |
FPA | K913661 |
| Aug 10, 2021 | B. Braun Medical, Inc. OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 490564 Terminated |
FPA | K140311 K913661 |
| Aug 10, 2021 | B. Braun Medical, Inc. OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 490361 Terminated |
FPA | K083723 K913661 |
| Aug 10, 2021 | B. Braun Medical, Inc. PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 480239 Terminated |
FPA | K140311 K913661 +1 |
| Aug 10, 2021 | B. Braun Medical, Inc. OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 477009 Terminated |
FPA | K140311 K913661 |
| Aug 10, 2021 | B. Braun Medical, Inc. Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 477005 Terminated |
FPA | K140311 K922637 |
| Aug 10, 2021 | B. Braun Medical, Inc. OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 474004 Terminated |
FPA | K083723 K904518 +1 |
| Aug 10, 2021 | B. Braun Medical, Inc. V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 470025 Terminated |
FPA | K913661 |
| Aug 10, 2021 | B. Braun Medical, Inc. ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 470024 Terminated |
FPA | K913661 |
| Aug 10, 2021 | B. Braun Medical, Inc. Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 375118 Terminated |
FPA | K781744 K913661 |
| Aug 10, 2021 | B. Braun Medical, Inc. 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 354216 Terminated |
FPA | K083723 K922637 |
| Aug 10, 2021 | B. Braun Medical, Inc. 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 354215 Terminated |
FPA | K083723 K781744 +1 |
| Aug 10, 2021 | B. Braun Medical, Inc. Outlook Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 35421 Terminated |
FPA | K083723 K913661 +1 |
| Aug 10, 2021 | B. Braun Medical, Inc. Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Material ID: 352413 Terminated |
FPA | K083723 K913661 |
| Aug 10, 2021 | B. Braun Medical, Inc. 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid
Material ID: 354212 Terminated |
FPA | K083723 K913661 |
| Aug 2, 2021 | CAREFUSION BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006 Open, Classified |
FPA | K970485 |
| Aug 2, 2021 | CAREFUSION BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Lue Open, Classified |
FPA | K960280 |
| Aug 2, 2021 | CAREFUSION BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006 Open, Classified |
FPA | K960280 |
| Aug 2, 2021 | CAREFUSION BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006 Open, Classified |
FPA | K931550 |
| Aug 2, 2021 | CAREFUSION BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 Open, Classified |
FPA | K780130 |
| Aug 2, 2021 | CAREFUSION BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522 Open, Classified |
FPA | K931173 |
| Aug 2, 2021 | CAREFUSION BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564 Open, Classified |
FPA | K951922 |
| Aug 2, 2021 | CAREFUSION BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E Open, Classified |
FPA | K970485 |
| Aug 2, 2021 | CAREFUSION BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010 Open, Classified |
FPA | K960280 |
| Aug 2, 2021 | CAREFUSION BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smart Open, Classified |
FPA | K944320 |
| Aug 2, 2021 | CAREFUSION BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E Open, Classified |
FPA | K820278 |
| Aug 2, 2021 | CAREFUSION BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703; Open, Classified |
FPA | K811885 |
| Aug 2, 2021 | CAREFUSION BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , Open, Classified |
FPA | K780130 |
| Aug 2, 2021 | CAREFUSION BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D Open, Classified |
FPA | K061285 |
| Aug 2, 2021 | CAREFUSION BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E Open, Classified |
FPA | K061285 |
| Jun 25, 2021 | B. Braun Medical, Inc. Infusomat Space Volumetric Pump Administration Set, Product Code 490100 Terminated |
FPA | K142036 |
| Jun 9, 2021 | CAREFUSION MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiratio Terminated |
FPA | None listed |
| Mar 16, 2021 | ICU Medical, Inc. REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or cathete Open, Classified |
FPA | K082806 |
| Mar 16, 2021 | ICU Medical, Inc. REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets Open, Classified |
FPA | K082806 |
| Mar 16, 2021 | ICU Medical, Inc. REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a conta Open, Classified |
FPA | K082806 |
| Mar 16, 2021 | ICU Medical, Inc. REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications. Open, Classified |
FPA | K081361 |
| Mar 16, 2021 | ICU Medical, Inc. REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications. Open, Classified |
FPA | K081361 |
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