Cleared Traditional

Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 241
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