Cleared Abbreviated

K024293 - BOWIE-DICK MINI PAK, MODEL BD 115

K024293 is an FDA 510(k) clearance for BOWIE-DICK MINI PAK, manufactured by Steritec Products, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Abbreviated 510(k) pathway after a 230-day FDA review.

K024293 · Steritec Products, Inc. · General Hospital
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Aug 2003
Decision
230d
Days
Class 2
Risk

K024293 is an FDA 510(k) clearance for the BOWIE-DICK MINI PAK, MODEL BD 115. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products, Inc. (Castle Rock, US). The FDA issued a Cleared decision on August 11, 2003 after a review of 230 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Steritec Products, Inc. devices

FDA 510(k) Submission Details - K024293

510(k) Number K024293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2002
Decision Date August 11, 2003
Days to Decision 230 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 129d · This submission: 230d
Pathway characteristics
Standards-based clearance path.

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 204
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K024293.
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
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MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
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K032801 · Albert Browne , Ltd. · Oct 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680 · Spsmedical Supply Corp. · May 2003
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · Advanced Sterilization Products · Oct 2002
STEAMPLUS STERILIZATION TEST
K020409 · Spsmedical Supply Corp. · Jul 2002