Cleared Traditional

K191236 - 3M Attest Steam Chemical Integrators

K191236 is the FDA 510(k) clearance for 3M Attest Steam Chemical Integrators by 3M Company. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K191236 · 3M Company · General Hospital
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Nov 2019
Decision
198d
Days
Class 2
Risk

K191236 is an FDA 510(k) clearance for the 3M™ Attest™ Steam Chemical Integrators. 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 November 22, 2019 after a review of 198 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.

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Submission Details

510(k) Number K191236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2019
Decision Date November 22, 2019
Days to Decision 198 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
69d slower than avg
Panel avg: 129d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K191236.
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 Integrator
K193254 · 3M Company · Dec 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K192937 · 3M Company · Nov 2019
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673 · 3M Company · Oct 2019
Sterilucent VH2O2 Chemical Indicators
K191999 · Sterilucent, Inc. · Oct 2019