Cleared Traditional

K932057 - BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK

K932057 is an FDA 510(k) clearance for BROWNE TST SINGLE USE BOWIE DICK TYPE T..., manufactured by Board of Directors, Albert Browne , Ltd.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 464-day FDA review.

K932057 · Board of Directors, Albert Browne , Ltd. · General Hospital
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Aug 1994
Decision
464d
Days
Class 2
Risk

K932057 is an FDA 510(k) clearance for the BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Board of Directors, Albert Browne , Ltd. (Leics. Le4 Oaa, GB). The FDA issued a Cleared decision on August 5, 1994 after a review of 464 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Board of Directors, Albert Browne , Ltd. devices

FDA 510(k) Submission Details - K932057

510(k) Number K932057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1993
Decision Date August 05, 1994
Days to Decision 464 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
335d slower than avg
Panel avg: 129d · This submission: 464d
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 207
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