510(k) K142036 ยท FPA Set, Administration, Intravascular
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
| Applicant | B.Braun Medical, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Aug 25, 2014 |
| Received | Jul 28, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc Infusomat 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 following Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362032 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication.
Model/Catalog Number: 362033 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362034 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362050 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362420 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362431 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 362432 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363010 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363030 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363420 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363421 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363422 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363423 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363424 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363430 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 363433 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 480254 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/Catalog Number: 480255 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number 480263 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490100 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490101 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number 490102 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490103 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number : 490104 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 490361 Open, Classified |
FPA | None listed |
| Jul 17, 2024 | B. Braun Medical, Inc. Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication
Model/ Catalog Number: 363230 Open, Classified |
FPA | None listed |
| Dec 1, 2023 | B. Braun Medical, Inc. Infusomat Administration Sets as listed below:
362031
Infusomat Space Pump Set with Caresite Injection Site;
362032
15 drops/mL, priming volume: 22mL, length: 119in, SafeLine;
362033
UNIV. 1 Open, Classified |
FPA | None listed |
| Jun 25, 2021 | B. Braun Medical, Inc. Infusomat Space Volumetric Pump Administration Set, Product Code 490100 Terminated |
FPA | None listed |
| Sep 23, 2019 | B. Braun Medical, Inc. B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 Terminated |
FPA | None listed |
| May 9, 2018 | B. Braun Medical, Inc. Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420
The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Va Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.