Remunity System
FDA 510(k) K243354 · Deka Research & Development Corp.
510(k) numberK243354
Submission
- Device name
- Remunity System
- Applicant
- Deka Research & Development Corp.
Manchester, NH, US - Received
- October 29, 2024
- Decision date
- November 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K240256 | Remunity SystemQJY · Traditional | Deka Research and Development | 06/12/2024SE |
| K202690 | Remunity Pump for Remodulin (treprostinil) InjectionQJY · Traditional | Deka Research and Development | 12/30/2020SE |
| K191313 | Unity Subcutaneous Infusion System for RemodulinQJY · Traditional | DEKA Research & Development | 02/21/2020SE |
More from DEKA Research & Development
| 510(k) | Device | Decision |
|---|---|---|
| K250930 | twiist systemQFG · Special | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | 03/11/2025SE |
| K191313 | Unity Subcutaneous Infusion System for RemodulinQJY · Traditional | 02/21/2020SE |
| K190182 | Unity Subcutaneous Delivery System for RemodulinFRN · Traditional | 05/06/2019SE |
| K172601 | Next Generation iBOTIMK · Traditional | 03/02/2018SE |
| K153760 | Volumetric Infusion ControllerLDR · Traditional | 10/03/2016SE |
| K124018 | Amia Automated PD SystemFKX · Traditional | 06/14/2013SE |
| K093915 | Deka Tac DeviceFIG · Traditional | 08/23/2011SE |
| K103220 | Voyager Peritoneal Dialysis SystemFKX · Traditional | 07/29/2011SE |
| K863204 | Deka Jr.LDR · Traditional | 09/03/1986SE |
Questions and answers
When was Remunity System cleared by the FDA?
Remunity System (K243354) received a 510(k) decision of Substantially Equivalent on November 27, 2024, 29 days after the submission was received.
What is the product code of K243354?
The FDA product code is QJY – Infusion Pump, Drug Specific, Pharmacy-Filled, a Class II (moderate risk) device regulated under 21 CFR 880.5725.