Cleared Traditional

K242538 - 3M™ Attest™ Super Rapid Readout Biological Indicator 1493

Also marketed or referenced as:
3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG 3M™ Attest™ Auto-reader 490 3M™ Attest™ Auto-reader 490H 3M™ Attest™ Mini Auto-reader 490M

K242538 is an FDA 510(k) clearance for 3M Attest Super Rapid Readout Biologica..., manufactured by 3M Company. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K242538 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
91d
Days
Class 2
Risk

K242538 is an FDA 510(k) clearance for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493. 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 November 25, 2024 after a review of 91 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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FDA 510(k) Submission Details - K242538

510(k) Number K242538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2024
Decision Date November 25, 2024
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K242538.
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K242453 · Terragene S.A. · Dec 2024
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD)
K241959 · 3M Company · Oct 2024
Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
K231383 · Terragene S.A. · Sep 2024
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K241710 · 3M Company · Sep 2024