Cleared Traditional

VERIFY VH2O2 Indicator Tape (K172753) - FDA 510(k) Clearance

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

K172753 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
150d
Days
Class 2
Risk

K172753 is an FDA 510(k) clearance for the VERIFY VH2O2 Indicator Tape. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on February 9, 2018 after a review of 150 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 STERIS Corporation devices

Submission Details

510(k) Number K172753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2017
Decision Date February 09, 2018
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOJ Indicator, Physical/chemical 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 - JOJ Indicator, Physical/chemical Sterilization Process

All 97
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K172753.
VERIFY Chemical Indicator for S40 Sterilant
K173428 · STERIS Corporation · Mar 2018
U&U Indicator tape and strip
K171823 · U&U Medical Technology Co, Ltd. · Feb 2018
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
K172746 · STERIS Corporation · Feb 2018
Micro-MEC 1.8% Glutaraldehyde Monitor Strip
K172472 · STERIS Corporation · Nov 2017
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K170321 · 3M Company · Aug 2017
3M Comply Hydrogen Peroxide Indicator Tape
K170563 · 3M Company · Jul 2017