Cleared Traditional

K965212 - STERITEC DISPOSABLE INTEGRATOR LOAD CHA...

K965212 is the FDA 510(k) clearance for STERITEC DISPOSABLE INTEGRATOR LOAD CHA... 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 482-day FDA review.

K965212 · Steritec Products Mfg Co, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
482d
Days
Class 2
Risk

K965212 is an FDA 510(k) clearance for the STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM. 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 April 23, 1998 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Steritec Products Mfg Co, Inc. devices

Submission Details

510(k) Number K965212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1996
Decision Date April 23, 1998
Days to Decision 482 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
353d slower than avg
Panel avg: 129d · This submission: 482d
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 K965212.
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K020589 · 3M Company · Apr 2002
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415 · Kimberly-Clark Corp. · Jul 1998
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K945190 · Advanced Sterilization Products · Dec 1994
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K932129 · 3M Company · Mar 1994
STERRAD CHEMICAL INDICATOR
K921910 · Johnson & Johnson Medical, Inc. · Oct 1993