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FDA 510(k)

Remunity 2.0 Pump for Remodulin (treprostinil) Injection

K-Number: K241736 · 2025-01-16

ApplicantDeka Research and Development Corp.
Decision Date2025-01-16
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Remunity 2.0 Pump for Remodulin (treprostinil) Injection is a medical device manufactured by Deka Research and Development Corp.. It received FDA 510(k) clearance on 2025-01-16 under approval number K241736. 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 Remunity 2.0 Pump for Remodulin (treprostinil) Injection?

Remunity 2.0 Pump for Remodulin (treprostinil) Injection is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Deka Research and Development Corp.. The 510(k) number is K241736.

When was Remunity 2.0 Pump for Remodulin (treprostinil) Injection approved by the FDA?

Remunity 2.0 Pump for Remodulin (treprostinil) Injection received FDA 510(k) clearance on 2025-01-16, under approval number K241736.

What company makes Remunity 2.0 Pump for Remodulin (treprostinil) Injection?

Remunity 2.0 Pump for Remodulin (treprostinil) Injection is manufactured by Deka Research and Development Corp..

What is the FDA product code for Remunity 2.0 Pump for Remodulin (treprostinil) Injection?

The FDA product code for Remunity 2.0 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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