Cleared Special

K052128 - 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER

K052128 is an FDA 510(k) clearance for 3M ATTEST 293 AUTO-READER, manufactured by 3M Company. The device is a Class 2 General Hospital device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K052128

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.

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 204
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K052128.
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
K071014 · Advanced Sterilization Products · May 2007
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
K051056 · Albert Browne , Ltd. · Oct 2005
STERRAD STERILIZER CYCLESURE TEST PACK
K051643 · Advanced Sterilization Products · Aug 2005
SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK
K051173 · Spsmedical Supply Corp. · May 2005
STERRAD NX CHALLENGE PACK
K042450 · Advanced Sterilization Products · May 2005
SPOR-TEST PA BIOLOGICAL INDICATOR KIT
K050664 · Getinge USA, Inc. · Apr 2005
K052128 · 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
Download PDF FDA Summary 3M Company