K243354 is an FDA 510(k) clearance for the Remunity System. This device is classified as a Infusion Pump, Drug Specific, Pharmacy-filled (Class II - Special Controls, product code QJY).
Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on November 27, 2024, 29 days after receiving the submission on October 29, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725. A Pharmacy-filled, Drug Specific Infusion System Is A Prescription Device Intended For Delivery Of A Specific Drug In Accordance With The Fda Approved Labeling And May Be Filled At A Location Other Than Point Of Care..
| 510(k) Number | K243354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2024 |
| Decision Date | November 27, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QJY - Infusion Pump, Drug Specific, Pharmacy-filled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | A Pharmacy-filled, Drug Specific Infusion System Is A Prescription Device Intended For Delivery Of A Specific Drug In Accordance With The Fda Approved Labeling And May Be Filled At A Location Other Than Point Of Care. |