Cleared Traditional

K031012 - ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294

Also marketed or referenced as:
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK

K031012 is an FDA 510(k) clearance for ATTEST RAPID READOUT BIOLOGICAL INDICAT..., manufactured by 3M Company. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K031012 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
199d
Days
Class 2
Risk

K031012 is an FDA 510(k) clearance for the ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294. 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 October 16, 2003 after a review of 199 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.

View all 3M Company devices

FDA 510(k) Submission Details - K031012

510(k) Number K031012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date October 16, 2003
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Citech
ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRC Indicator, Biological Sterilization Process

All 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K031012.
RAVEN PROTEST - EO
K041784 · Raven Biological Laboratories, Inc. · Sep 2004
RAVEN PROTEST - STEAM
K041386 · Raven Biological Laboratories, Inc. · Aug 2004
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K041099 · Spsmedical Supply Corp. · May 2004
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K031226 · Advanced Sterilization Products · May 2003
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K023716 · Spsmedical Supply Corp. · Dec 2002
SPSMEDICAL SPORVIEW STEAM BI TEST PACK
K022706 · Spsmedical Supply Corp. · Oct 2002

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.