Cleared Traditional

K961156 - ONCE-A-DAY BOWIE AND DICK TEST PACK. (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961156 · Propper Mfg. Co., Inc. · General Hospital
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Apr 1997
Decision
375d
Days
Class 2
Risk

K961156 is an FDA 510(k) clearance for the ONCE-A-DAY BOWIE AND DICK TEST PACK.. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Propper Mfg. Co., Inc. (Long Island, US). The FDA issued a Cleared decision on April 1, 1997 after a review of 375 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 Propper Mfg. Co., Inc. devices

Submission Details

510(k) Number K961156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1996
Decision Date April 01, 1997
Days to Decision 375 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
247d slower than avg
Panel avg: 128d · This submission: 375d
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 264
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