Cleared Traditional

K010534 - CROSS-CHECKS DUAL, MODEL CI 125

K010534 is an FDA 510(k) clearance for CROSS-CHECKS DUAL, manufactured by Steritec Products, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K010534 · Steritec Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
164d
Days
Class 2
Risk

K010534 is an FDA 510(k) clearance for the CROSS-CHECKS DUAL, MODEL CI 125. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products, Inc. (Castle Rock, US). The FDA issued a Cleared decision on August 6, 2001 after a review of 164 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 Steritec Products, Inc. devices

FDA 510(k) Submission Details - K010534

510(k) Number K010534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2001
Decision Date August 06, 2001
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
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 204
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K010534.
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
K002741 · Albert Browne , Ltd. · Jul 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · 3M Company · Apr 2002
BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS
K012335 · Albert Browne , Ltd. · Oct 2001
STEAM/EO RECORD CARD, MODEL CI 121
K000502 · Steritec Products Mfg Co, Inc. · Mar 2000
BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K992767 · Albert Browne , Ltd. · Jan 2000
CIDEX OPA SOLUTION TEST STRIP
K992341 · Serim Research Corp. · Nov 1999