Cleared Traditional

K130160 - VERIFY PROCESS INDICATOR FOR RELIANCE EPS

K130160 is an FDA 510(k) clearance for VERIFY PROCESS INDICATOR FOR RELIANCE EPS, 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 205-day FDA review.

K130160 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K130160

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.

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 249
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K130160.
AIRVIEW MINI OWIE DICK TEST PACK
K133204 · Crosstex International · May 2014
STERITEC GREEN CARD PACK BOWIE-DICK TEST
K132372 · Steritec Products Mfg Co, Inc. · Nov 2013
DANA REUSABLE BI TEST PACK
K130135 · Dana Products, Inc. · Nov 2013
AIRVIEW BOWIE DICK
K130211 · Spsmedical Supply Corp. · Jul 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
K122945 · Steritec Products Mfg Co, Inc. · Apr 2013
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
K120592 · Dana Products, Inc. · Feb 2013
K130160 · VERIFY PROCESS INDICATOR FOR RELIANCE EPS
Download PDF FDA Summary STERIS Corporation