Cleared Abbreviated

K112256 - STERIS STEAM PI

K112256 is the FDA 510(k) clearance for STERIS STEAM PI 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.

K112256 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
159d
Days
Class 2
Risk

K112256 is an FDA 510(k) clearance for the STERIS STEAM PI. 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 January 11, 2012 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 K112256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2011
Decision Date January 11, 2012
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 107
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K112256.
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
K111518 · Advanced Sterilization Products · Oct 2012
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
K111519 · Advanced Sterilization Products · Oct 2012
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
K120435 · STERIS Corporation · Jun 2012
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
K103331 · STERIS Corporation · Sep 2011
STERRAD CHEMICAL INDICATOR STRIP
K103218 · Advanced Sterilization Products · Apr 2011
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K103219 · Advanced Sterilization Products · Apr 2011