Cleared Traditional

K843182 - MASTER-CHEK BOWIE-DICK TYPE TEST

K843182 is an FDA 510(k) clearance for MASTER-CHEK BOWIE-DICK TYPE TEST, manufactured by Arvey Corp.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K843182 · Arvey Corp. · General Hospital
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Oct 1984
Decision
57d
Days
Class 2
Risk

K843182 is an FDA 510(k) clearance for the MASTER-CHEK BOWIE-DICK TYPE TEST. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Arvey Corp. (Chicago, US). The FDA issued a Cleared decision on October 9, 1984 after a review of 57 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 Arvey Corp. devices

FDA 510(k) Submission Details - K843182

510(k) Number K843182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date October 09, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
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 239
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K843182.
STRIP, STERILIZATION INDICATOR
K890765 · Spsmedical Supply Corp. · Aug 1989
BIO-CHALLENGE TEST PAK
K851804 · Propper Mfg. Co., Inc. · Jul 1985
DART DAILY AIR REMOVAL TEST
K844512 · American Sterilizer Co. · Mar 1985
STERILIZATION PROCESS INDICATOR
K841168 · Parke-Davis Co. · May 1984
OK FLASH STERILIZATION INDICATOR
K834353 · Propper Mfg. Co., Inc. · Mar 1984
CASTLE TEC-TEST S.M.A.R.T. PACK
K833074 · Castle Co. · Nov 1983