Cleared Traditional

K960089 - PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR

K960089 is an FDA 510(k) clearance for PROCHEK G GLUTARALDEHYDE CONCENTRATION ..., manufactured by Cottrell, Ltd.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K960089 · Cottrell, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
84d
Days
Class 2
Risk

K960089 is an FDA 510(k) clearance for the PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Cottrell, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 84 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cottrell, Ltd. devices

FDA 510(k) Submission Details - K960089

510(k) Number K960089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date April 04, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
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 202
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K960089.
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
CROSS-CHECKS EO GAS STERILIZATION MONITOR
K952244 · Steritec Products Mfg Co, Inc. · Aug 1996
STERITEC CROSS-CHECKS
K955426 · Steritec Products Mfg Co, Inc. · Mar 1996
ATI ETHYLENE OXIDE STERILIZATION INDICATOR
K952995 · Pymah Corp. · Feb 1996
ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
K952408 · Pymah Corp. · Jul 1995