Cleared Traditional

K982151 - STERITITE PROCESS INDICATOR ACCESSORIES

K982151 is an FDA 510(k) clearance for STERITITE PROCESS INDICATOR ACCESSORIES, manufactured by Case Medical, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K982151 · Case Medical, Inc. · General Hospital
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Feb 1999
Decision
236d
Days
Class 2
Risk

K982151 is an FDA 510(k) clearance for the STERITITE PROCESS INDICATOR ACCESSORIES. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Case Medical, Inc. (Ridgefield, US). The FDA issued a Cleared decision on February 9, 1999 after a review of 236 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 Case Medical, Inc. devices

FDA 510(k) Submission Details - K982151

510(k) Number K982151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1998
Decision Date February 09, 1999
Days to Decision 236 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 129d · This submission: 236d
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 159
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K982151.
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
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CIDEX OPA SOLUTION TEST STRIP
K992341 · Serim Research Corp. · Nov 1999
PASS/FAIL CHALLENGE PACK
K991276 · Propper Mfg. Co., Inc. · Jul 1999
PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
K973585 · Propper Mfg. Co., Inc. · Nov 1998
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415 · Kimberly-Clark Corp. · Jul 1998
SPOROX TEST STRIPS
K972035 · Serim Research Corp. · Aug 1997