Cleared Traditional

K183211 - 3M Comply Hydrogen Peroxide Chemical Indicator

K183211 is an FDA 510(k) clearance for 3M Comply Hydrogen Peroxide Chemical In..., manufactured by 3M Company. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K183211 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
99d
Days
Class 2
Risk

K183211 is an FDA 510(k) clearance for the 3M Comply Hydrogen Peroxide Chemical Indicator. 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 February 26, 2019 after a review of 99 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 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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FDA 510(k) Submission Details - K183211

510(k) Number K183211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date February 26, 2019
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

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 217
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K183211.
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
K192020 · STERIS Corporation · Sep 2019
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
K191741 · Intertape Polymer, Inc. · Aug 2019
Lead-free Chemical Indicators for Steam Sterilization
K181788 · Kem Medical Products Corp. · Mar 2019
3M Comply Hydrogen Peroxide Indicator Tape
K183209 · 3M Company · Feb 2019
VERIFY VH202 Indicator Tape
K183293 · STERIS Corporation · Jan 2019
Celerity HP Chemical Indicator (CI)
K183295 · Steris Corporations · Jan 2019