Cleared Traditional

3MTM AttestTM Mini Auto-reader 490M (K200092) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200092 · 3M · General Hospital
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Apr 2020
Decision
90d
Days
Class 2
Risk

K200092 is an FDA 510(k) clearance for the 3MTM AttestTM Mini Auto-reader 490M. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by 3M (St. Paul, US). The FDA issued a Cleared decision on April 15, 2020 after a review of 90 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.

View all 3M devices

Submission Details

510(k) Number K200092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2020
Decision Date April 15, 2020
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRC Indicator, Biological 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 - FRC Indicator, Biological Sterilization Process

All 88
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K200092.
3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H
K192550 · 3M Company · Jun 2020
3MTM AttestTM Rapid 5 Steam-Plus Test Pack
K200536 · 3M Complany · Jun 2020
VERIFY Assert Self-Contained Biological Indicator
K200126 · STERIS Corporation · May 2020
3M Attest Super Rapid 5 Steam-Plus Challenge Pack
K193154 · 3M Company · Feb 2020
STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
K192025 · Advanced Sterilization Products (Asp) · Jan 2020
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
K192001 · Sterilucent, Inc. · Oct 2019