Cleared Special

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (K203284) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K203284 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
28d
Days
Class 2
Risk

K203284 is an FDA 510(k) clearance for the 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator. Classified as A Chemical Vapor Sterilization Multivariable Chemical Indicator (product code QKM), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on December 7, 2020 after a review of 28 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 K203284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2020
Decision Date December 07, 2020
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
Definition A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process.
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 - QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator

Devices cleared under the same product code (QKM) and FDA review panel - the closest regulatory comparables to K203284.
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
K232103 · Terragene S.A. · Apr 2024
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K212022 · 3M Company · Apr 2022
CELERITY HP Chemical Indicator
K213262 · STERIS Corporation · Jan 2022
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K193110 · 3M Healthcare · Mar 2020