Cleared Traditional

K170039 - STERRAD VELOCITY Biological Indictator and Reader

K170039 is an FDA 510(k) clearance for STERRAD VELOCITY Biological Indictator ..., manufactured by Advanced Sterilization Products (Asp). The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K170039 · Advanced Sterilization Products (Asp) · General Hospital
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Jun 2017
Decision
166d
Days
Class 2
Risk

K170039 is an FDA 510(k) clearance for the STERRAD VELOCITY Biological Indictator 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 June 20, 2017 after a review of 166 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

FDA 510(k) Submission Details - K170039

510(k) Number K170039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2017
Decision Date June 20, 2017
Days to Decision 166 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 129d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRC Device Classification - Class 2, Special Controls

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 154
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K170039.
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K170070 · STERIS Corporation · Apr 2017
3M Attest Rapid Readout Biological Indicator
K160546 · 3M Company · Jun 2016
3M Attest Rapid Readout Biological Indicator 1295
K152060 · 3M Company · Dec 2015