Cleared Traditional

K982547 - STERITEC CROSS-CHECKS EO GAS STERILIZAT...

K982547 is the FDA 510(k) clearance for STERITEC CROSS-CHECKS EO GAS STERILIZAT... by Steritec Products Mfg Co, Inc.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K982547 · Steritec Products Mfg Co, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
79d
Days
Class 2
Risk

K982547 is an FDA 510(k) clearance for the STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products Mfg Co, Inc. (Castle Rock, US). The FDA issued a Cleared decision on October 8, 1998 after a review of 79 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 Steritec Products Mfg Co, Inc. devices

Submission Details

510(k) Number K982547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1998
Decision Date October 08, 1998
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 115
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K982547.
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