K232316 is an FDA 510(k) clearance for the DEKA Infusion System, DEKA Administration Set. This device is classified as a Controller, Infusion, Intravascular, Electronic (Class II - Special Controls, product code LDR).
Submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on March 1, 2024, 211 days after receiving the submission on August 3, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K232316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2023 |
| Decision Date | March 01, 2024 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LDR - Controller, Infusion, Intravascular, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |