510(k) K202618 ยท FPA Set, Administration, Intravascular
IV Administration Sets
| Applicant | B.Braun Medical, Inc., Allentown PA, US |
| Decision | Substantially Equivalent, Sep 24, 2021 |
| Received | Sep 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202618
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B Braun Medical Inc RATE FLOW 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 follow Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.