Cleared Traditional

K991709 - BROWNE CIDEX OPA INDICATOR

K991709 is an FDA 510(k) clearance for BROWNE CIDEX OPA 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 142-day FDA review.

K991709 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
142d
Days
Class 2
Risk

K991709 is an FDA 510(k) clearance for the BROWNE CIDEX OPA 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 October 8, 1999 after a review of 142 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 Albert Browne , Ltd. devices

FDA 510(k) Submission Details - K991709

510(k) Number K991709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1999
Decision Date October 08, 1999
Days to Decision 142 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
13d slower than avg
Panel avg: 129d · This submission: 142d
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 K991709.
STEAM/EO RECORD CARD, MODEL CI 121
K000502 · Steritec Products Mfg Co, Inc. · Mar 2000
BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K992767 · Albert Browne , Ltd. · Jan 2000
CIDEX OPA SOLUTION TEST STRIP
K992341 · Serim Research Corp. · Nov 1999
PASS/FAIL CHALLENGE PACK
K991276 · Propper Mfg. Co., Inc. · Jul 1999
STERI-PAK LF BOWIE-DICK TEST PACK
K990246 · Steritec Products Mfg Co, Inc. · Jun 1999
BROWNE MVI ETHYLENE OXIDE INDICATOR
K991418 · Albert Browne , Ltd. · Jun 1999