Cleared Traditional

K130160 - VERIFY PROCESS INDICATOR FOR RELIANCE EPS

K130160 is the FDA 510(k) clearance for VERIFY PROCESS INDICATOR FOR RELIANCE EPS by STERIS Corporation. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K130160 · STERIS Corporation · General Hospital
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Aug 2013
Decision
205d
Days
Class 2
Risk

K130160 is an FDA 510(k) clearance for the VERIFY PROCESS INDICATOR FOR RELIANCE EPS. 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 August 16, 2013 after a review of 205 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 K130160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2013
Decision Date August 16, 2013
Days to Decision 205 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
76d slower than avg
Panel avg: 129d · This submission: 205d
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 99
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K130160.
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization
K150477 · 3M Company · Jul 2015
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K143333 · STERIS Corporation · Apr 2015
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
K140515 · STERIS Corporation · Jul 2014
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
K120435 · STERIS Corporation · Jun 2012
STERIS STEAM PI
K112256 · STERIS Corporation · Jan 2012
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
K103331 · STERIS Corporation · Sep 2011