K243841 is an FDA 510(k) clearance for the Sparta Infusion Set for Insulin. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on August 1, 2025, 231 days after receiving the submission on December 13, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K243841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2024 |
| Decision Date | August 01, 2025 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |