ClearanceBrief
510(k) K913661 ยท FRN Pump, Infusion

MODIFIED VOLUMETRIC INFUSION PUMP

ApplicantMcgaw, Inc., Irvine CA, US
DecisionSubstantially Equivalent, Dec 18, 1991
ReceivedAug 2, 1991
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K913661

DateFirm and productCodeLinked 510(k)
Nov 26, 2025B Braun Medical Inc
Outlook 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
Outlook 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
Outlook 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
Outlook 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
Jul 17, 2024B. Braun Medical, Inc.
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
Open, Classified
FPANone listed
Jul 17, 2024B. Braun Medical, Inc.
OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
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.
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
Terminated
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
Terminated
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 35421
Terminated
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
Terminated
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
Terminated
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
Terminated
FPANone listed
Aug 10, 2021B. Braun Medical, Inc.
V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
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, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
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
Aug 10, 2021B. Braun Medical, Inc.
Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Terminated
FPANone listed

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