Cleared Traditional

K102761 - DANA REUSABLE TEST PACK FOR STEAM STERILIZATION

K102761 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 JOJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K102761 · Dana Products, Inc. · General Hospital
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Dec 2010
Decision
88d
Days
Class 2
Risk

K102761 is an FDA 510(k) clearance for the DANA REUSABLE TEST PACK FOR STEAM STERILIZATION. 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 December 20, 2010 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dana Products, Inc. devices

FDA 510(k) Submission Details - K102761

510(k) Number K102761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2010
Decision Date December 20, 2010
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 K102761.
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