Unity Subcutaneous Delivery System for Remodulin
FDA 510(k) K190182 · DEKA Research & Development
510(k) numberK190182
Submission
- Device name
- Unity Subcutaneous Delivery System for Remodulin
- Applicant
- DEKA Research & Development
Manchester, NH, US - Received
- February 1, 2019
- Decision date
- May 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code FRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K250930 | twiist systemQFG · Special | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | 03/11/2025SE |
| K243354 | Remunity SystemQJY · Special | 11/27/2024SE |
| K191313 | Unity Subcutaneous Infusion System for RemodulinQJY · Traditional | 02/21/2020SE |
| 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 Unity Subcutaneous Delivery System for Remodulin cleared by the FDA?
Unity Subcutaneous Delivery System for Remodulin (K190182) received a 510(k) decision of Substantially Equivalent on May 6, 2019, 94 days after the submission was received.
What is the product code of K190182?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.