K214045 is an FDA 510(k) clearance for the FreedomEdge Syringe Infusion System. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Repro-Medical System, Inc., Dba Koru Medical Systems (New York, US). The FDA issued a Cleared decision on April 29, 2022, 123 days after receiving the submission on December 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K214045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | April 29, 2022 |
| Days to Decision | 123 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 |