510(k) K922637 ยท FPA Set, Administration, Intravascular
HORIZON PUMP Y-TYPE BLOOD SET
| Applicant | Mcgaw, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 4, 1993 |
| Received | Jun 4, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922637
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B 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 |
FPA | None listed |
| Nov 26, 2025 | B 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 |
FPA | None listed |
| Nov 26, 2025 | B 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 |
FPA | None listed |
| Aug 10, 2021 | B. Braun Medical, Inc. 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids
Ref: 354216 Terminated |
FPA | None listed |
| Aug 10, 2021 | B. 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 |
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. Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 Terminated |
FPA | None listed |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490314 Terminated |
FPA | None listed |
| Nov 20, 2019 | B. Braun Medical, Inc. Y-Type Blood Set, Catalog Number 490530 Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Y Type Blood Set with 170um Blood Filter, Injection Site, Spin Lock Connector, 131 in Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.