Cleared Traditional

K123546 - 3M ATTEST(TM) AUTO-READER

K123546 is the FDA 510(k) clearance for 3M ATTEST(TM) AUTO-READER by 3M Company. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K123546 · 3M Company · General Hospital
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Mar 2013
Decision
119d
Days
Class 2
Risk

K123546 is an FDA 510(k) clearance for the 3M ATTEST(TM) AUTO-READER. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on March 18, 2013 after a review of 119 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 Company devices

Submission Details

510(k) Number K123546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date March 18, 2013
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 89
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K123546.
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K121593 · 3M Company · Mar 2013
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