Cleared Traditional

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD) (K233814) - FDA 510(k) Clearance

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

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

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

Submission Details

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.

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 88
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