Cleared Traditional

Unity Subcutaneous Infusion System for Remodulin (K191313) - FDA 510(k) Clearance

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

K191313 · DEKA Research & Development · General Hospital
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Feb 2020
Decision
282d
Days
Class 2
Risk

K191313 is an FDA 510(k) clearance for the Unity Subcutaneous Infusion System for Remodulin. Classified as Infusion Pump, Drug Specific, Pharmacy-filled (product code QJY), Class II - Special Controls.

Submitted by DEKA Research & Development (Manchester, US). The FDA issued a Cleared decision on February 21, 2020 after a review of 282 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.

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Submission Details

510(k) Number K191313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2019
Decision Date February 21, 2020
Days to Decision 282 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
153d slower than avg
Panel avg: 129d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJY Infusion Pump, Drug Specific, Pharmacy-filled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition A Pharmacy-filled, Drug Specific Infusion System Is A Prescription Device Intended For Delivery Of A Specific Drug In Accordance With The Fda Approved Labeling And May Be Filled At A Location Other Than Point Of Care.
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.