510(k) K931377 ยท FPA Set, Administration, Intravascular
SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT
| Applicant | Mcgaw, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 7, 1994 |
| Received | Mar 18, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931377
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the follow Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th Open, Classified |
FPA | None listed |
| Nov 26, 2025 | B Braun Medical Inc SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followi Open, Classified |
FPA | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Nov 20, 2019 | B. Braun Medical, Inc. Safeline Y-Type Blood Set, Catalog Number NF5140 Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 118 in NF1500M3HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Ultrasite Inj Sites, B/C Valve, 2 N/C Valves Stopcock, 116 in US1500M2HP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. 15 Drop Universal IV Admin Set w Outlook Cassette Ultrasites and Ultraport Stopcock 132 in US1501UPHP Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Pressure limited check Valve, Spin Lock Connector, 3 Safeline Inj Sites, 120 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site, 170um Blood Filter, Spin lock Connector 138 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Safeline Injection Sites, Spin Lock Connector 120 in Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.