K202690 is an FDA 510(k) clearance for the Remunity Pump for Remodulin (treprostinil) Injection. This device is classified as a Infusion Pump, Drug Specific, Pharmacy-filled (Class II - Special Controls, product code QJY).
Submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on December 30, 2020, 106 days after receiving the submission on September 15, 2020.
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 | K202690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2020 |
| Decision Date | December 30, 2020 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| 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. |