Cleared Special

K052128 - 3M ATTEST 293 AUTO-READER

K052128 is the FDA 510(k) clearance for 3M ATTEST 293 AUTO-READER by 3M Company. It is a Class 2 General Hospital device (product code FRC) cleared through the Special 510(k) pathway after a 11-day FDA review.

K052128 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
11d
Days
Class 2
Risk

K052128 is an FDA 510(k) clearance for the 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER. 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 August 16, 2005 after a review of 11 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K052128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2005
Decision Date August 16, 2005
Days to Decision 11 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
118d faster than avg
Panel avg: 129d · This submission: 11d
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 K052128.
STERRAD 100NX TEST PACK
K071537 · Advanced Sterilization Products · Dec 2007
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
K071014 · Advanced Sterilization Products · May 2007
STERRAD STERILIZER CYCLESURE TEST PACK
K051643 · Advanced Sterilization Products · Aug 2005
STERRAD NX CHALLENGE PACK
K042450 · Advanced Sterilization Products · May 2005
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294
K031012 · 3M Company · Oct 2003
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K031226 · Advanced Sterilization Products · May 2003