510(k) K913661 ยท FRN Pump, Infusion
MODIFIED VOLUMETRIC INFUSION PUMP
| Applicant | Mcgaw, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 18, 1991 |
| Received | Aug 2, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B 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 |
FPA | None listed |
| Nov 26, 2025 | B 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 |
FPA | None listed |
| Nov 26, 2025 | B 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 |
FPA | None listed |
| Nov 26, 2025 | B 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 |
FPA | None listed |
| Jul 17, 2024 | B. 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 |
FPA | None listed |
| Jul 17, 2024 | B. 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 |
FPA | None listed |
| Jul 17, 2024 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
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 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.