Cleared Traditional

Unity Subcutaneous Delivery System for Remodulin (K190182) - FDA 510(k) Clearance

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

K190182 · DEKA Research & Development · General Hospital
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May 2019
Decision
94d
Days
Class 2
Risk

K190182 is an FDA 510(k) clearance for the Unity Subcutaneous Delivery System for Remodulin. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by DEKA Research & Development (Manchester, US). The FDA issued a Cleared decision on May 6, 2019 after a review of 94 days - within the typical 510(k) review window.

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 & Development devices

Submission Details

510(k) Number K190182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2019
Decision Date May 06, 2019
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
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 847
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K190182.
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