Cleared Traditional

K192025 - STERRAD VELOCITY Biological Indicator/P...

K192025 is the FDA 510(k) clearance for STERRAD VELOCITY Biological Indicator/P... by Advanced Sterilization Products (Asp). It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K192025 · Advanced Sterilization Products (Asp) · General Hospital
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Jan 2020
Decision
178d
Days
Class 2
Risk

K192025 is an FDA 510(k) clearance for the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Asp) (Irvin, US). The FDA issued a Cleared decision on January 23, 2020 after a review of 178 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 Advanced Sterilization Products (Asp) devices

Submission Details

510(k) Number K192025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date January 23, 2020
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRC Indicator, Biological Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 - FRC Indicator, Biological Sterilization Process

All 89
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K192025.
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