Cleared Special

K240717 - 3M Attest Rapid Readout Biological Indi...

K240717 is the FDA 510(k) clearance for 3M Attest Rapid Readout Biological Indi... by 3M Company. It is a Class 2 General Hospital device (product code FRC) cleared through the Special 510(k) pathway after a 104-day FDA review.

K240717 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
104d
Days
Class 2
Risk

K240717 is an FDA 510(k) clearance for the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized.... 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 June 27, 2024 after a review of 104 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all 3M Company devices

Submission Details

510(k) Number K240717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2024
Decision Date June 27, 2024
Days to Decision 104 days
Submission Type Special
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
25d faster than avg
Panel avg: 129d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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 114
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K240717.
3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD)
K241959 · 3M Company · Oct 2024
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K233814 · 3M Company · Mar 2024
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K233681 · STERIS Corporation · Dec 2023