Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736)
Description
Remunity 2.0 Pump for Remodulin (treprostinil) Injection by Deka Research and Development Corp., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241736
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233952 | DEKA ACE Pump System | Deka Research and Development | 2024 |
| K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | 2019 |
| K042172 | CLEO 90 INFUSION SET | Smiths Medical MD, Inc. | 2004 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025 |
Trace the full predicate network for K241736
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.