Cleared Traditional

K902958 - TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE

K902958 is an FDA 510(k) clearance for TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE, 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 119-day FDA review.

K902958 · Board of Directors, Albert Browne , Ltd. · General Hospital
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Nov 1990
Decision
119d
Days
Class 2
Risk

K902958 is an FDA 510(k) clearance for the TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Board of Directors, Albert Browne , Ltd. (Leics. Le4 Oaa, GB). The FDA issued a Cleared decision on November 1, 1990 after a review of 119 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 - K902958

510(k) Number K902958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1990
Decision Date November 01, 1990
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
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 207
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K902958.
STERRAD CHEMICAL INDICATOR
K921910 · Johnson & Johnson Medical, Inc. · Oct 1993
CHEMDI-VHP CHEMICAL INDICATOR
K922485 · American Sterilizer Co. · Sep 1993
SERIM PERACETIC ACID REAGENT STRIPS
K910320 · Serim Research Corp. · May 1991
STEAMLINE
K895910 · Propper Mfg. Co., Inc. · Aug 1990
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · Edward Weck, Inc. · Feb 1990
TOWER SELF SEAL STERILIZATION POUCH
K895422 · Baxter Healthcare Corp · Nov 1989