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FDA 510(k)

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection

K-Number: K250357 · 2025-03-11

ApplicantDeka Research & Development Corp.
Decision Date2025-03-11
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is a medical device manufactured by Deka Research & Development Corp.. It received FDA 510(k) clearance on 2025-03-11 under approval number K250357. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RemunityPRO™ Pump for Remodulin® (treprostinil) Injection?

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is a medical device that received FDA 510(k) clearance on 2025-03-11. It is manufactured by Deka Research & Development Corp.. The 510(k) number is K250357.

When was RemunityPRO™ Pump for Remodulin® (treprostinil) Injection approved by the FDA?

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection received FDA 510(k) clearance on 2025-03-11, under approval number K250357.

What company makes RemunityPRO™ Pump for Remodulin® (treprostinil) Injection?

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is manufactured by Deka Research & Development Corp..

What is the FDA product code for RemunityPRO™ Pump for Remodulin® (treprostinil) Injection?

The FDA product code for RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is FRN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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