Cleared Traditional

K233814 - 3M Attest Super Rapid Vaporized Hydroge...

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

K233814 is an FDA 510(k) clearance for 3M Attest Super Rapid Vaporized Hydroge..., 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 106-day FDA review.

K233814 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
106d
Days
Class 2
Risk

K233814 is an FDA 510(k) clearance for the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (129.... 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 15, 2024 after a review of 106 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 - K233814

510(k) Number K233814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2023
Decision Date March 15, 2024
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 136
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K233814.
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
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)
K241542 · 3M Company · Jun 2024
ConFirm 20 Minute Incubator
K233681 · STERIS Corporation · Dec 2023
Celerity 20 HP Biological Indicator
K231490 · STERIS Corporation · Aug 2023
Celerity Incubator
K223715 · STERIS Corporation · Jun 2023