Cleared Traditional

K241736 - Remunity 2.0 Pump for Remodulin (trepro...

K241736 is an FDA 510(k) clearance for Remunity 2.0 Pump for Remodulin (trepro..., manufactured by Deka Research and Development Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K241736 · Deka Research and Development Corp. · General Hospital
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Jan 2025
Decision
213d
Days
Class 2
Risk

K241736 is an FDA 510(k) clearance for the Remunity 2.0 Pump for Remodulin (treprostinil) Injection. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Deka Research and Development Corp. (Manchester, US). The FDA issued a Cleared decision on January 16, 2025 after a review of 213 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 Research and Development Corp. devices

FDA 510(k) Submission Details - K241736

510(k) Number K241736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2024
Decision Date January 16, 2025
Days to Decision 213 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 129d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 464
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K241736.
Plum Solo™ Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025
Plum Duo™ Precision IV Pump
K242115 · Icu Medical, Inc. · Apr 2025
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
K250357 · Deka Research & Development Corp. · Mar 2025
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min)
K242735 · Belmont Medical Technologies · Dec 2024
Curlin 8000 Ambulatory Infusion System
K242660 · Zevex, Inc. · Oct 2024
Novum IQ Syringe Pump (40800BAXUS)
K242390 · Baxter Healthcare Corporation · Sep 2024