Cleared Traditional

VERIFY Assert VH2O2 Self-Contained Biological Indicator (K171504) - FDA 510(k) Clearance

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

K171504 · STERIS Corporation · General Hospital
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Aug 2017
Decision
91d
Days
Class 2
Risk

K171504 is an FDA 510(k) clearance for the VERIFY Assert VH2O2 Self-Contained Biological Indicator. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 22, 2017 after a review of 91 days - within the typical 510(k) review window.

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 STERIS Corporation devices

Submission Details

510(k) Number K171504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2017
Decision Date August 22, 2017
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K171504.
Sporview VH202 BI
K171287 · Spsmedical Supply Corp. A Division of Cantel Medical · Feb 2018
3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader
K173584 · 3M Company · Jan 2018
Celerity 20 HP Biological Indicator
K172474 · STERIS Corporation · Dec 2017
VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
K171587 · STERIS Corporation · Aug 2017
3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
K171003 · 3M Company · Jul 2017
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
K170070 · STERIS Corporation · Apr 2017