K242735 is an FDA 510(k) clearance for the Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min). This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Belmont Medical Technologies (Billerica, US). The FDA issued a Cleared decision on December 23, 2024, 103 days after receiving the submission on September 11, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K242735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2024 |
| Decision Date | December 23, 2024 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |