Cleared Special

K060103 - ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS

K060103 is an FDA 510(k) clearance for ALBERT BROWNE LTD. VERIFY STEAM VALUE I..., 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 53-day FDA review.

K060103 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
53d
Days
Class 2
Risk

K060103 is an FDA 510(k) clearance for the ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS. 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 March 7, 2006 after a review of 53 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 - K060103

510(k) Number K060103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2006
Decision Date March 07, 2006
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 K060103.
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
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K060066 · Albert Browne , Ltd. · Mar 2006
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K051101 · Albert Browne , Ltd. · Dec 2005
SERIM PERACETIC ACID CHEMICAL INDICATOR
K052388 · Serim Research Corp. · Dec 2005
STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137
K052516 · Steritec Products, Inc. · Oct 2005
K060103 · ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
Download PDF FDA Summary Albert Browne , Ltd.