Cleared Traditional

K103277 - 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR

Also marketed or referenced as:
3M ATTEST 490 AUTO-READER

K103277 is an FDA 510(k) clearance for 3M ATTEST 1491 SUPER RAPID READOUT BIOL..., manufactured by 3M Company-3M Health Care. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K103277 · 3M Company-3M Health Care · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
165d
Days
Class 2
Risk

K103277 is an FDA 510(k) clearance for the 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by 3M Company-3M Health Care (St. Paul, US). The FDA issued a Cleared decision on April 19, 2011 after a review of 165 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K103277

510(k) Number K103277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2010
Decision Date April 19, 2011
Days to Decision 165 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
36d slower than avg
Panel avg: 129d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 187
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K103277.
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STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K111150 · Steritec Products Mfg Co, Inc. · Jul 2011
STERRAAD 100NX EXPRESS CYCLE TEST PACK
K092755 · Advanced Sterilization Products · Feb 2011
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · Advanced Sterilization Products · Feb 2011
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
K103321 · Dana Products, Inc. · Feb 2011