Cleared Abbreviated

K991418 - BROWNE MVI ETHYLENE OXIDE INDICATOR

K991418 is an FDA 510(k) clearance for BROWNE MVI ETHYLENE OXIDE INDICATOR, manufactured by Albert Browne , Ltd.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Abbreviated 510(k) pathway after a 48-day FDA review.

K991418 · Albert Browne , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
48d
Days
Class 2
Risk

K991418 is an FDA 510(k) clearance for the BROWNE MVI ETHYLENE OXIDE 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 June 10, 1999 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Albert Browne , Ltd. devices

FDA 510(k) Submission Details - K991418

510(k) Number K991418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1999
Decision Date June 10, 1999
Days to Decision 48 days
Submission Type Abbreviated
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
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Standards-based clearance path.

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 K991418.
BROWNE CIDEX OPA INDICATOR
K991709 · Albert Browne , Ltd. · Oct 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 SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K984613 · Albert Browne , Ltd. · Feb 1999
BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K984616 · Albert Browne , Ltd. · Feb 1999
BROWNE GA INDICATOR FOR CIDEX PRODUCTS
K981054 · Albert Browne , Ltd. · Dec 1998