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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 the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 2025-03-11 under 510(k) 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. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K250357.

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 2025-03-11, under 510(k) number K250357.

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

The FDA 510(k) record lists Deka Research & Development 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.

Other records listing Deka Research & Development Corp. as applicant

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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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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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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