ClearanceBrief
510(k) K140311 ยท FPA Set, Administration, Intravascular

CARESITE LUER ACCESS DEVICE

ApplicantB.Braun Medical, Inc., Allentown PA, US
DecisionSubstantially Equivalent, May 7, 2014
ReceivedFeb 7, 2014
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K140311

DateFirm and productCodeLinked 510(k)
Nov 26, 2025B Braun Medical Inc
Blood 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
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
Blood 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
Open, Classified
FPANone listed
Nov 26, 2025B Braun Medical Inc
Burette 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 followin
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
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
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
Jul 17, 2024B. Braun Medical, Inc.
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
Open, Classified
FPANone listed
Aug 10, 2021B. 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
FPANone listed
Aug 10, 2021B. 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
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 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
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Terminated
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490314
Terminated
FPANone listed
Nov 20, 2019B. Braun Medical, Inc.
Y-Type Blood Set, Catalog Number 490530
Terminated
FPANone listed

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