Cleared Traditional

BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK (K932057) - FDA 510(k) Clearance

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

K932057 · Board of Directors, Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 96
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K932057.
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
K070461 · STERIS Corporation · Jul 2007
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002
3M AUTOCLAVE TAPES
K932129 · 3M Company · Mar 1994
TOWER SELF SEAL STERILIZATION POUCH
K895422 · Baxter Healthcare Corp · Nov 1989
3M STEAM STERILIZATION INDICATOR
K801057 · 3M Company · Jun 1980