Cleared Traditional

K241959 - 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD)

Also marketed or referenced as:
3M™ Attest™ Auto-reader (490) 3M™ Attest™ Auto-reader (490H) 3M™ Attest™ Mini Auto-reader (490M)

K241959 is an FDA 510(k) clearance for 3M Attest Super Rapid Steam Clear Chall..., 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 107-day FDA review.

K241959 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
107d
Days
Class 2
Risk

K241959 is an FDA 510(k) clearance for the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD). 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 October 18, 2024 after a review of 107 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

FDA 510(k) Submission Details - K241959

510(k) Number K241959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2024
Decision Date October 18, 2024
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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 K241959.
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE
K243501 · 3M Company · Jan 2025
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2)
K242453 · Terragene S.A. · Dec 2024
3M™ Attest™ Super Rapid Readout Biological Indicator 1493
K242538 · 3M Company · Nov 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
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V
K241710 · 3M Company · Sep 2024
3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K240717 · 3M Company · Jun 2024