Cleared Special

K032801 - MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR

K032801 is an FDA 510(k) clearance for MODIFIED BROWNE PACKAGING AND LABEL STE..., manufactured by Albert Browne , Ltd.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Special 510(k) pathway after a 38-day FDA review.

K032801 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
38d
Days
Class 2
Risk

K032801 is an FDA 510(k) clearance for the MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Albert Browne , Ltd. (North Attleboro, US). The FDA issued a Cleared decision on October 17, 2003 after a review of 38 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032801

510(k) Number K032801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2003
Decision Date October 17, 2003
Days to Decision 38 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

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 247
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K032801.
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
K031152 · Propper Mfg. Co., Inc. · Aug 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · Spsmedical Supply Corp. · Jun 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · Advanced Sterilization Products · Apr 2004
TSO3 OZONE CHEMICAL INDICATOR
K021161 · Technologies of Sterilization With Oxone, Tso3, Inc. · Aug 2003
BOWIE-DICK MINI PAK, MODEL BD 115
K024293 · Steritec Products, Inc. · Aug 2003
BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K031647 · Getinge USA, Inc. · Jul 2003
K032801 · MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
Download PDF FDA Summary Albert Browne , Ltd.