510(k) K242735 ยท FRN Pump, Infusion
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
| Applicant | Belmont Medical Technologies, Billerica MA, US |
| Decision | Substantially Equivalent, Dec 23, 2024 |
| Received | Sep 11, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242735
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2025 | Belmont Instrument LLC 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032.
The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The Open, Classified |
LGZ | None listed |
| Feb 4, 2025 | Belmont Instrument LLC Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.