Cleared Traditional

K200092 - 3MTM AttestTM Mini Auto-reader 490M

K200092 is an FDA 510(k) clearance for 3MTM AttestTM Mini Auto-reader 490M, manufactured by 3M. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K200092 · 3M · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K200092

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.

FRC Device Classification - Class 2, Special Controls

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 127
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