Cleared Traditional

K143629 - U&U Bowie-Dick Test Pack

K143629 is the FDA 510(k) clearance for U&U Bowie-Dick Test Pack by U&U Medical Technology Co, Ltd.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K143629 · U&U Medical Technology Co, Ltd. · General Hospital
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May 2015
Decision
148d
Days
Class 2
Risk

K143629 is an FDA 510(k) clearance for the U&U Bowie-Dick Test Pack. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by U&U Medical Technology Co, Ltd. (Changzhou, CN). The FDA issued a Cleared decision on May 19, 2015 after a review of 148 days - within the typical 510(k) review window.

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 U&U Medical Technology Co, Ltd. devices

Submission Details

510(k) Number K143629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date May 19, 2015
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 115
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