Cleared Special

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (K250357) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250357 · Deka Research & Development Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
32d
Days
Class 2
Risk

K250357 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 Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on March 11, 2025 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Deka Research & Development Corp. devices

Submission Details

510(k) Number K250357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2025
Decision Date March 11, 2025
Days to Decision 32 days
Submission Type Special
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
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K250357.
BD Alaris Infusion System with Guardrails Suite MX
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Plum Solo™ Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025
Plum Duo™ Precision IV Pump
K242115 · Icu Medical, Inc. · Apr 2025
Remunity 2.0 Pump for Remodulin (treprostinil) Injection
K241736 · Deka Research and Development Corp. · Jan 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