Cleared Traditional

K152630 - VERIFY STEAM Integrating Indicator

K152630 is an FDA 510(k) clearance for VERIFY STEAM Integrating Indicator, 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 240-day FDA review.

K152630 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
240d
Days
Class 2
Risk

K152630 is an FDA 510(k) clearance for the VERIFY STEAM Integrating Indicator. 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 May 12, 2016 after a review of 240 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 - K152630

510(k) Number K152630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2015
Decision Date May 12, 2016
Days to Decision 240 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
111d slower than avg
Panel avg: 129d · This submission: 240d
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 191
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K152630.
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
K162758 · STERIS Corporation · Mar 2017
VERIFY STEAM Integrating Indicator - Short
K162631 · STERIS Corporation · Jan 2017
VERIFY VH2O2 Indicator Tape
K160485 · STERIS Corporation · Jun 2016
AN1087 Dosimeter
K150645 · Andersen Sterilizers, Inc. · Nov 2015
AN85/AN86 EO Indicators
K150644 · Andersen Sterilizers, Inc. · Nov 2015
3M Comply Hydrogen Peroxide Indicator Tape 1228
K150694 · 3M Company · Oct 2015