Cleared Abbreviated

K071895 - VERIFY 275 DEGREE F. 3-10 INDICATOR

Also marketed or referenced as:
10 INDICATOR 3 INDICATOR

K071895 is the FDA 510(k) clearance for VERIFY 275 DEGREE F. 3-10 INDICATOR by STERIS Corporation. It is a Class 2 General Hospital device (product code JOJ) cleared through the Abbreviated 510(k) pathway after a 128-day FDA review.

K071895 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
128d
Days
Class 2
Risk

K071895 is an FDA 510(k) clearance for the VERIFY 275 DEGREE F. 3-10 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 November 14, 2007 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all STERIS Corporation devices

Submission Details

510(k) Number K071895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2007
Decision Date November 14, 2007
Days to Decision 128 days
Submission Type Abbreviated
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
1d faster than avg
Panel avg: 129d · This submission: 128d
Pathway characteristics
Standards-based clearance path.

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 114
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K071895.
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K072510 · STERIS Corporation · Dec 2007
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K070895 · STERIS Corporation · Sep 2007
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K070461 · STERIS Corporation · Jul 2007
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004