Cleared Traditional

BROWNE STEAM INDICATOR (K970918) - FDA 510(k) Clearance

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

K970918 · Board of Directors, Albert Browne , Ltd. · General Hospital
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Jun 1997
Decision
104d
Days
Class 2
Risk

K970918 is an FDA 510(k) clearance for the BROWNE STEAM INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Board of Directors, Albert Browne , Ltd. (North Attleboro, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Board of Directors, Albert Browne , Ltd. devices

Submission Details

510(k) Number K970918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1997
Decision Date June 24, 1997
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 129d · This submission: 104d
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
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K895422 · Baxter Healthcare Corp · Nov 1989
3M STEAM STERILIZATION INDICATOR
K801057 · 3M Company · Jun 1980