Cleared Traditional

K132344 - E-Z CHECK OZONE TEST STRIPS

K132344 is an FDA 510(k) clearance for E-Z CHECK OZONE TEST STRIPS, manufactured by Reprocessing Products Corporation (Rpc). The device is a Class 2 Gastroenterology & Urology device with product code MSY cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K132344 · Reprocessing Products Corporation (Rpc) · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
211d
Days
Class 2
Risk

K132344 is an FDA 510(k) clearance for the E-Z CHECK OZONE TEST STRIPS. Classified as Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (product code MSY), Class II - Special Controls.

Submitted by Reprocessing Products Corporation (Rpc) (Tucson, US). The FDA issued a Cleared decision on February 25, 2014 after a review of 211 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Reprocessing Products Corporation (Rpc) devices

FDA 510(k) Submission Details - K132344

510(k) Number K132344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2013
Decision Date February 25, 2014
Days to Decision 211 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 130d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSY Device Classification - Class 2, Special Controls

Product Code MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Devices cleared under the same product code (MSY) and FDA review panel - the closest regulatory comparables to K132344.
Chlorine Sentinel II
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K193169 · Nelson Environmental Technologies, Inc. · Oct 2020
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K080712 · Serim Research Corp. · May 2008