Cleared Traditional

ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (K926364) - FDA 510(k) Clearance

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

K926364 · 3M Health Care, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
829d
Days
Class 2
Risk

K926364 is an FDA 510(k) clearance for the ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 829 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 Health Care, Ltd. devices

Submission Details

510(k) Number K926364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1992
Decision Date March 31, 1995
Days to Decision 829 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
700d slower than avg
Panel avg: 129d · This submission: 829d
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 89
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K926364.
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
K052128 · 3M Company · Aug 2005
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294
K031012 · 3M Company · Oct 2003
3M ATTEST 290 AUTO-READER
K004009 · 3M Company · Mar 2002
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
TRAVASPORE BIOLOGICAL INDICATOR
K832922 · Travenol Laboratories, S.A. · Nov 1983