Cleared Traditional

K172753 - VERIFY VH2O2 Indicator Tape

K172753 is an FDA 510(k) clearance for VERIFY VH2O2 Indicator Tape, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 150-day FDA review.

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

FDA 510(k) Submission Details - K172753

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.

JOJ Device Classification - Class 2, Special Controls

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 171
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