Cleared Special

K212081 - 3M(TM) Comply(TM) Hydrogen Peroxide Ind...

K212081 is the FDA 510(k) clearance for 3M(TM) Comply(TM) Hydrogen Peroxide Ind... by 3M Company. It is a Class 2 General Hospital device (product code JOJ) cleared through the Special 510(k) pathway after a 65-day FDA review.

K212081 · 3M Company · General Hospital
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Sep 2021
Decision
65d
Days
Class 2
Risk

K212081 is an FDA 510(k) clearance for the 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228. 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 September 5, 2021 after a review of 65 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.

View all 3M Company devices

Submission Details

510(k) Number K212081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2021
Decision Date September 05, 2021
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 K212081.
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