Cleared Traditional

K253703 - RemunityPRO+ Pump for Remodulin (trepro...

K253703 is the FDA 510(k) clearance for RemunityPRO+ Pump for Remodulin (trepro... by Deka R&D Corp. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K253703 · Deka R&D Corp · General Hospital
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Jul 2026
Decision
242d
Days
Class 2
Risk

K253703 is an FDA 510(k) clearance for the RemunityPRO+ Pump for Remodulin® (treprostinil) Injection. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Deka R&D Corp (Manchester, US). The FDA issued a Cleared decision on July 24, 2026 after a review of 242 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Deka R&D Corp devices

Submission Details

510(k) Number K253703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2025
Decision Date July 24, 2026
Days to Decision 242 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 129d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 434
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K253703.
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K252015 · Koru Medical Systems, Inc. · Jan 2026
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · Baxter Healthcare Corporation · Jul 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · Baxter Healthcare Corporation · Jul 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · Iradimed Corporation · May 2025
BD Alaris Infusion System with Guardrails Suite MX
K243855 · Carefusion 303, Inc. · Apr 2025
Plum Solo™ Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025