Cleared Traditional

K971369 - BROWNE MVI STEAM INDICATOR

K971369 is an FDA 510(k) clearance for BROWNE MVI STEAM INDICATOR, 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 290-day FDA review.

K971369 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
290d
Days
Class 2
Risk

K971369 is an FDA 510(k) clearance for the BROWNE MVI STEAM INDICATOR. 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 January 29, 1998 after a review of 290 days - an extended review 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: 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 Albert Browne , Ltd. devices

FDA 510(k) Submission Details - K971369

510(k) Number K971369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1997
Decision Date January 29, 1998
Days to Decision 290 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
161d slower than avg
Panel avg: 129d · This submission: 290d
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 K971369.
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415 · Kimberly-Clark Corp. · Jul 1998
STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM
K965212 · Steritec Products Mfg Co, Inc. · Apr 1998
CROSS-CHECKS P
K972300 · Steritec Products Mfg Co, Inc. · Mar 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