Cleared Traditional

K955426 - STERITEC CROSS-CHECKS

K955426 is an FDA 510(k) clearance for STERITEC CROSS-CHECKS, manufactured by Steritec Products Mfg Co, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K955426 · Steritec Products Mfg Co, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
105d
Days
Class 2
Risk

K955426 is an FDA 510(k) clearance for the STERITEC CROSS-CHECKS. 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 March 12, 1996 after a review of 105 days - within the typical 510(k) review window.

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 Steritec Products Mfg Co, Inc. devices

FDA 510(k) Submission Details - K955426

510(k) Number K955426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1995
Decision Date March 12, 1996
Days to Decision 105 days
Submission Type Traditional
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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 217
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K955426.
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K960089 · Cottrell, Ltd. · Apr 1996
ATI ETHYLENE OXIDE STERILIZATION INDICATOR
K952995 · Pymah Corp. · Feb 1996
ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
K952408 · Pymah Corp. · Jul 1995
ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION
K951063 · Pymah Corp. · May 1995