Remunity Pump for Remodulin (treprostinil) Injection
FDA 510(k) K202690 · Deka Research and Development
510(k) numberK202690
Submission
- Device name
- Remunity Pump for Remodulin (treprostinil) Injection
- Applicant
- Deka Research and Development
Manchester, NH, US - Received
- September 15, 2020
- Decision date
- December 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJY – Infusion Pump, Drug Specific, Pharmacy-Filled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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.
Other 510(k)s with product code QJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243354 | Remunity SystemQJY · Special | Deka Research & Development Corp. | 11/27/2024SE |
| K240256 | Remunity SystemQJY · Traditional | Deka Research and Development | 06/12/2024SE |
| K191313 | Unity Subcutaneous Infusion System for RemodulinQJY · Traditional | DEKA Research & Development | 02/21/2020SE |
More from DEKA Research & Development
| 510(k) | Device | Decision |
|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) SystemQFG · Special | 06/17/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | 06/03/2026SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | 08/01/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | 01/16/2025SE |
| K242693 | DEKA Infusion System, DEKA Administration SetLDR · Special | 10/07/2024SE |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS)KPO · Traditional | 07/12/2024SE |
| K233557 | HemoCare Hemodialysis SystemKDI · Traditional | 07/12/2024SE |
| K240256 | Remunity SystemQJY · Traditional | 06/12/2024SE |
| K241178 | DEKA ACE Pump SystemQFG · Special | 05/24/2024SE |
| K234055 | DEKA LoopQJI · Traditional | 03/13/2024SE |
Questions and answers
When was Remunity Pump for Remodulin (treprostinil) Injection cleared by the FDA?
Remunity Pump for Remodulin (treprostinil) Injection (K202690) received a 510(k) decision of Substantially Equivalent on December 30, 2020, 106 days after the submission was received.
What is the product code of K202690?
The FDA product code is QJY – Infusion Pump, Drug Specific, Pharmacy-Filled, a Class II (moderate risk) device regulated under 21 CFR 880.5725.