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FDA 510(k)

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

K-Number: K253703 · 2026-07-24

ApplicantDeka R&D Corp
Decision Date2026-07-24
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection is the device name listed in this FDA 510(k) record. The listed applicant is Deka R&D Corp. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K253703. 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 2026-07-24. The listed applicant is Deka R&D Corp. The 510(k) number is K253703.

When did RemunityPRO+ Pump for Remodulin® (treprostinil) Injection receive FDA 510(k) clearance?

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection received FDA 510(k) clearance on 2026-07-24, under 510(k) number K253703.

Who is the listed applicant for RemunityPRO+ Pump for Remodulin® (treprostinil) Injection?

The FDA 510(k) record lists Deka R&D Corp as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: FRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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