Company ยท US
CAREFUSION
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2020. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
31recalls (0 in 12 months)
29recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2022 | CAREFUSION BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171 Open, Classified |
FPA | K051499 |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166 Open, Classified |
FPA | K051499 |
| 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 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 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 |
| Apr 15, 2013 | Carefusion Corporation Alaris PC unit model 8015 with software version 9.12
Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Terminated |
FRN | K051641 |
| Apr 15, 2013 | Carefusion Corporation Alaris PC unit model 8015 with software version 9.12
Product Usage:
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System Terminated |
FRN | K051641 |
| Mar 28, 2013 | CareFusion Corporation Pyxis Anesthesia System Model 2000 (PAS 2000)
Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist a Terminated |
BRY | None listed |
| Oct 13, 2010 | CareFusion Corporation CareFusion Alaris PC Unit Model 8015 (formerly Medley
PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December
20, 2008 and May 6, 2009 Terminated |
FRN | K051641 |
| Aug 2, 2010 | CareFusion Corporation Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module Terminated |
FRN | K051641 |
| Apr 7, 2010 | CareFusion NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711. Terminated |
GWQ | K991054 |