Cleared Traditional

K092944 - DANA REUSABLE TEST PACK FOR STEAM STERILIZATION

K092944 is an FDA 510(k) clearance for DANA REUSABLE TEST PACK FOR STEAM STERI..., manufactured by Dana Products, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K092944 · Dana Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
175d
Days
Class 2
Risk

K092944 is an FDA 510(k) clearance for the DANA REUSABLE TEST PACK FOR STEAM STERILIZATION. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Dana Products, Inc. (South Barrington, US). The FDA issued a Cleared decision on March 18, 2010 after a review of 175 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 Dana Products, Inc. devices

FDA 510(k) Submission Details - K092944

510(k) Number K092944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2009
Decision Date March 18, 2010
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 148
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K092944.
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · Advanced Sterilization Products · Feb 2011
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
K102884 · Advanced Sterilization Products · Jan 2011
3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
K101910 · 3M Company · Dec 2010
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION
K092906 · STERIS Corporation · Dec 2009
VERIFY SCBI 275F 3-10
K083665 · STERIS Corporation · Sep 2009
MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292
K090569 · 3M Company · Apr 2009