510(k) K954123 ยท FPA Set, Administration, Intravascular
LOW PROFILE SAFSITE Y-SITE
| Applicant | B.Braun Medical, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Nov 21, 1995 |
| Received | Sep 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc ADDitIV 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 wi Open, Classified |
FPA | None listed |
| Oct 14, 2022 | B. Braun Medical, Inc. Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon i Open, Classified |
FPA | None listed |
| Feb 18, 2014 | B. Braun Medical, Inc. SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.
A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set with Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, Spin Lock Connector 122 in Terminated |
FPA | None listed |
| Jan 26, 2010 | B. Braun Medical, Inc. Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.