Cleared Traditional

K061738 - ALBERT BROWNE LTD. VERIFY STEAM AND EO ...

K061738 is an FDA 510(k) clearance for ALBERT BROWNE LTD. VERIFY STEAM AND EO ..., manufactured by 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 66-day FDA review.

K061738 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
66d
Days
Class 2
Risk

K061738 is an FDA 510(k) clearance for the ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD. 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 August 25, 2006 after a review of 66 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Albert Browne , Ltd. devices

FDA 510(k) Submission Details - K061738

510(k) Number K061738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2006
Decision Date August 25, 2006
Days to Decision 66 days
Submission Type Traditional
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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 193
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K061738.
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