Cleared Abbreviated

K070895 - VERIFY CHALLENGE PACKS

Also marketed or referenced as:
275F 3 CHALLENGE PACK 275F 10 CHALLENGE PACK

K070895 is the FDA 510(k) clearance for VERIFY CHALLENGE PACKS by STERIS Corporation. It is a Class 2 General Hospital device (product code JOJ) cleared through the Abbreviated 510(k) pathway after a 159-day FDA review.

K070895 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
159d
Days
Class 2
Risk

K070895 is an FDA 510(k) clearance for the VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK. 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 September 5, 2007 after a review of 159 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 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 K070895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2007
Decision Date September 05, 2007
Days to Decision 159 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
30d slower than avg
Panel avg: 129d · This submission: 159d
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 K070895.
VERIFY CHALLENGE PACKS - VERSION 2
K073683 · STERIS Corporation · Jan 2008
VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2
K072510 · STERIS Corporation · Dec 2007
VERIFY 275 DEGREE F. 3-10 INDICATOR
K071895 · STERIS Corporation · Nov 2007
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
K070461 · STERIS Corporation · Jul 2007
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · Advanced Sterilization Products · Apr 2004