Cleared Traditional

VERIFY Assert Self-Contained Biological Indicator (K162701) - FDA 510(k) Clearance

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

K162701 · STERIS Corporation · General Hospital
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Mar 2017
Decision
177d
Days
Class 2
Risk

K162701 is an FDA 510(k) clearance for the VERIFY Assert Self-Contained Biological Indicator. Classified as Biological Sterilization Process Indicator With Recombinant-dna Plasmid (product code OWP), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 24, 2017 after a review of 177 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2805 - 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 K162701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2016
Decision Date March 24, 2017
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWP Biological Sterilization Process Indicator With Recombinant-dna Plasmid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2805
Definition A Recombinant-dna Plasmid Biological Indicator Is Intended For Use By A Health Care Provider To Accompany Products Being Sterilized Through A Sterilization Procedure And To Monitor Adequacy Of Sterilization.
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 - OWP Biological Sterilization Process Indicator With Recombinant-dna Plasmid

Devices cleared under the same product code (OWP) and FDA review panel - the closest regulatory comparables to K162701.
VERIFY Assert Self-Contained Biological Indicator
K181442 · STERIS Corporation · Jun 2018
VERIFY ASSERT STEAM Process Challenge Device
K162945 · STERIS Corporation · Apr 2017
VERIFY Incubator for Assert Self Contained Biological Indicators
K163587 · STERIS Corporation · Mar 2017
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
DEN110006 · STERIS Corporation · Jul 2013