Cleared Traditional

K133204 - AIRVIEW MINI OWIE DICK TEST PACK

K133204 is an FDA 510(k) clearance for AIRVIEW MINI OWIE DICK TEST PACK, manufactured by Crosstex International. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K133204 · Crosstex International · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
200d
Days
Class 2
Risk

K133204 is an FDA 510(k) clearance for the AIRVIEW MINI OWIE DICK TEST PACK. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Crosstex International (Rush, US). The FDA issued a Cleared decision on May 5, 2014 after a review of 200 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.

FDA 510(k) Submission Details - K133204

510(k) Number K133204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date May 05, 2014
Days to Decision 200 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
71d slower than avg
Panel avg: 129d · This submission: 200d
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 247
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K133204.
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
K140940 · Canadian Technical Tape, Ltd. · Oct 2014
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
K140515 · STERIS Corporation · Jul 2014
NAMSA CHEMICAL PROCESS
K132291 · North American Science Assoc., Inc. · May 2014
STERITEC GREEN CARD PACK BOWIE-DICK TEST
K132372 · Steritec Products Mfg Co, Inc. · Nov 2013
DANA REUSABLE BI TEST PACK
K130135 · Dana Products, Inc. · Nov 2013
VERIFY PROCESS INDICATOR FOR RELIANCE EPS
K130160 · STERIS Corporation · Aug 2013
K133204 · AIRVIEW MINI OWIE DICK TEST PACK
Download PDF FDA Summary Crosstex International