Cleared Traditional

3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader (K171003) - FDA 510(k) Clearance

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

K171003 · 3M Company · General Hospital
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Jul 2017
Decision
108d
Days
Class 2
Risk

K171003 is an FDA 510(k) clearance for the 3M Attest Rapid Readout Biological Indicator, 3M Attest 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 July 21, 2017 after a review of 108 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.

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Submission Details

510(k) Number K171003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2017
Decision Date July 21, 2017
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
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
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K152060 · 3M Company · Dec 2015