K252518 is an FDA 510(k) clearance for the DuoprossTM Smart Cap (Type I). This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Duopross Meditech Corporate (Farmingdale, US). The FDA issued a Cleared decision on December 17, 2025, 128 days after receiving the submission on August 11, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K252518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2025 |
| Decision Date | December 17, 2025 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |