Cleared Traditional

K120592 - DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS

K120592 is an FDA 510(k) clearance for DANA REUSABLE BOWIE TEST PACK FOR DANA ..., manufactured by Dana Products, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K120592 · Dana Products, Inc. · General Hospital
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Feb 2013
Decision
365d
Days
Class 2
Risk

K120592 is an FDA 510(k) clearance for the DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Dana Products, Inc. (South Barrington, US). The FDA issued a Cleared decision on February 27, 2013 after a review of 365 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K120592

510(k) Number K120592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date February 27, 2013
Days to Decision 365 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 129d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical 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 - JOJ Indicator, Physical/chemical Sterilization Process

All 194
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K120592.
VERIFY PROCESS INDICATOR FOR RELIANCE EPS
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K120652 · Serim Research Corp. · Oct 2012
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
K111518 · Advanced Sterilization Products · Oct 2012