ClearanceBrief
510(k) K931377 ยท FPA Set, Administration, Intravascular

SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT

ApplicantMcgaw, Inc., Irvine CA, US
DecisionSubstantially Equivalent, Mar 7, 1994
ReceivedMar 18, 1993
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K931377

DateFirm and productCodeLinked 510(k)
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Nov 26, 2025B 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
FPANone listed
Aug 10, 2021B. 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
FPANone listed
Aug 10, 2021B. 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
FPANone listed
Aug 10, 2021B. 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
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Safeline Y-Type Blood Set, Catalog Number NF5140
Terminated
FPANone listed
Jan 26, 2010B. 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
FPANone listed
Jan 26, 2010B. 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
FPANone listed
Jan 26, 2010B. Braun Medical, Inc.
15 Drop Universal IV Admin Set w Outlook Cassette Ultrasites and Ultraport Stopcock 132 in US1501UPHP
Terminated
FPANone listed
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Pressure limited check Valve, Spin Lock Connector, 3 Safeline Inj Sites, 120 in
Terminated
FPANone listed
Jan 26, 2010B. Braun Medical, Inc.
Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site, 170um Blood Filter, Spin lock Connector 138 in
Terminated
FPANone listed
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Safeline Injection Sites, Spin Lock Connector 120 in
Terminated
FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.