510(k) K904518 ยท FRN Pump, Infusion
VOLUMETRIC INFUSION PUMP
| Applicant | Kendall Mcgaw Laboratories, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 17, 1990 |
| Received | Oct 3, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904518
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| Sep 6, 2013 | B. Braun Medical, Inc. Outlook Safety Infusion System Burette Set.
For intravenous fluid administration. Terminated |
FRN | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Add On Set with Ultrasite Injection Site Spin Lock Connector 88 in US3110 Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Injection Site 0.2um Filter Spin Lock Connector 115 in V7416F Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Safesite Inj Sites, Check Valve 120 in SS3115M Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/15um Filter & Inj Site, Check Valve, 2 Inj Sites, 120 in V7421M Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set with Universal Spike and Spin Lock Connector 133 in 1500HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Supor Membrane 1.2um Filter, Spin Lock Connector 123 in 1500FHP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike & Spin Lock Connector 118 in V1500HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 1 Safeline & 3 Ultrasite Inj Sites, Check Valve, B/C Valve 119 in US1500XHP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj Sites, 3 B/C Valves, Spin Lock Connector 140 in US1504HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike Pressure Limited Check Valve, 2 B/C Valves, 3 Ultrasite Inj Sites, 137 in US1505HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Back Check Valve, Ultrasite Inj Site, Spin Lock Connector, 128 in US1506HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um Filter, Spin Lock Connector, 120 in US3112F Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Check Valve, 4 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 138 in NF1501M3HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Check Valve, 5 Ultrasite Inj Sites, Ultraport HF Stopcock, 148 in US1500UPHP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin Lock Con & Pressure Limited Check Valve, 127 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Add On Set with Injection Site & Spin Lock Connector, 90 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Syringe Add On Set w/Microbore Tubing, Injection Site, Spin Lock Connector, 88 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Add On Set for Epidural Administration w/Microbore tubing & Sliding Spin Lock Connector, 88 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Injection Site & Spin Lock Connector, 132 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set with Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Lock Connector, 132 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Lock Connector, 132 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Nitroglycerin Set w/Universal Spike & Spin Lock Connector, 135 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set for Epidural Admin w/Universal Spike, Microbore Tubing, Spin Lock Connector, 126 in Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520.
For us Terminated |
FPA | None listed |
| Jun 5, 2009 | B. Braun Medical, Inc. Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite Injection Site and Spin-Lock Connector, Catalog #470046.
For use with the Horizon NXT Pump, and OutLook Safety I Terminated |
FPA | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product i Terminated |
FRN | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Saf Terminated |
FRN | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Out Terminated |
FRN | None listed |
| Sep 23, 2008 | B. Braun Medical, Inc. Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlo Terminated |
FPA | None listed |
| May 31, 2007 | B. Braun Medical, Inc. Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets. Terminated |
FPA | None listed |
| May 31, 2007 | B. Braun Medical, Inc. Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.