Cleared Traditional

K101910 - 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS

K101910 is an FDA 510(k) clearance for 3M ATTEST RAPID READOUT STEAM PROCESS C..., 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 152-day FDA review.

K101910 · 3M Company · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
152d
Days
Class 2
Risk

K101910 is an FDA 510(k) clearance for the 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTES.... 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 December 8, 2010 after a review of 152 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.

FDA 510(k) Submission Details - K101910

510(k) Number K101910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2010
Decision Date December 08, 2010
Days to Decision 152 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
23d slower than avg
Panel avg: 129d · This submission: 152d
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 199
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K101910.
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STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
K102884 · Advanced Sterilization Products · Jan 2011
SMART-READ EZTEST-STEAM SCBI AND TEST PACK
K093794 · Sgm Biotech, Inc. · May 2010
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
K092944 · Dana Products, Inc. · Mar 2010
SMART-WELL EZTEST INCUBATOR
K091950 · Sgm Biotech, Inc. · Jan 2010
K101910 · 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
Download PDF FDA Summary 3M Company