Cleared Special

K193254 - 3M Attest Steam Chemical Integrator

K193254 is the FDA 510(k) clearance for 3M Attest Steam Chemical Integrator by 3M Company. It is a Class 2 General Hospital device (product code JOJ) cleared through the Special 510(k) pathway after a 27-day FDA review.

K193254 · 3M Company · General Hospital
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Dec 2019
Decision
27d
Days
Class 2
Risk

K193254 is an FDA 510(k) clearance for the 3M Attest Steam Chemical Integrator. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on December 23, 2019 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K193254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2019
Decision Date December 23, 2019
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K193254.
Terragene Chemdye
K200272 · Terragene S.A. · Jun 2020
Getinge Assured MI Steam Migrating Integrator
K200252 · Steritec Products Mfg Co, Inc. · May 2020
QwikCheck Chemical Indicators
K192445 · Serim Research Corporation · Apr 2020
3M™ Attest™ Steam Chemical Integrators
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3M Comply Hydrogen Peroxide Chemical Indicator
K192937 · 3M Company · Nov 2019
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673 · 3M Company · Oct 2019