Cleared Traditional

K961156 - ONCE-A-DAY BOWIE AND DICK TEST PACK.

K961156 is an FDA 510(k) clearance for ONCE-A-DAY BOWIE AND DICK TEST PACK., manufactured by Propper Mfg. Co., Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 375-day FDA review.

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

FDA 510(k) Submission Details - K961156

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 129d · This submission: 375d
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 162
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K961156.
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR
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KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415 · Kimberly-Clark Corp. · Jul 1998
SPOROX TEST STRIPS
K972035 · Serim Research Corp. · Aug 1997
STERRAD CHEMICAL INDICATOR TAPE
K945190 · Advanced Sterilization Products · Dec 1994
3M AUTOCLAVE TAPES
K932129 · 3M Company · Mar 1994
ENDPOINT 500 PERACETIC ACID TEST INDICATORS
K931935 · Minntech Corp. · Feb 1994