Cleared Traditional

K004009 - 3M ATTEST 290 AUTO-READER

K004009 is the FDA 510(k) clearance for 3M ATTEST 290 AUTO-READER by 3M Company. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 454-day FDA review.

K004009 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
454d
Days
Class 2
Risk

K004009 is an FDA 510(k) clearance for the 3M ATTEST 290 AUTO-READER. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by 3M Company (Minneapolis, US). The FDA issued a Cleared decision on March 25, 2002 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all 3M Company devices

Submission Details

510(k) Number K004009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date March 25, 2002
Days to Decision 454 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
325d slower than avg
Panel avg: 129d · This submission: 454d
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 114
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K004009.
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
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K994055 · Advanced Sterilization Products · Feb 2002
STERRAD BI TEST PACK
K993775 · Advanced Sterilization Products · Jun 2000
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · Advanced Sterilization Products · Jun 1999