Cleared Traditional

K970918 - BROWNE STEAM INDICATOR

K970918 is an FDA 510(k) clearance for BROWNE STEAM INDICATOR, manufactured by Board of Directors, 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 104-day FDA review.

K970918 · Board of Directors, Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K970918

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
Combination Product No
PCCP Authorized No
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.

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 206
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K970918.
BROWNE MVI STEAM INDICATOR
K971369 · Albert Browne , Ltd. · Jan 1998
GLUTATECT
K971888 · Alden Scientific, Inc. · Jan 1998
SPOROX TEST STRIPS
K972035 · Serim Research Corp. · Aug 1997
STERITEC INTEGRAPH MODEL CI-101
K960441 · Steritec Products Mfg Co, Inc. · May 1997
STERITEC DRY HEAT INDICATOR LABEL
K953122 · Steritec Products Mfg Co, Inc. · Apr 1997
ONCE-A-DAY BOWIE AND DICK TEST PACK.
K961156 · Propper Mfg. Co., Inc. · Apr 1997