Cleared Traditional

K143333 - Revital-Ox RESERT Solution Test Strip

K143333 is an FDA 510(k) clearance for Revital-Ox RESERT Solution Test Strip, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K143333 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
145d
Days
Class 2
Risk

K143333 is an FDA 510(k) clearance for the Revital-Ox RESERT Solution Test Strip. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 14, 2015 after a review of 145 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.

FDA 510(k) Submission Details - K143333

510(k) Number K143333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2014
Decision Date April 14, 2015
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
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 K143333.
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization
K150477 · 3M Company · Jul 2015
SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)
K143520 · Crosstex · Jun 2015
U&U Bowie-Dick Test Pack
K143629 · U&U Medical Technology Co, Ltd. · May 2015
STERIZONE CHEMICAL INDICATOR
K141698 · Tso3, Inc. · Dec 2014
SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE
K140566 · Crosstex International · Nov 2014
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
K140940 · Canadian Technical Tape, Ltd. · Oct 2014
K143333 · Revital-Ox RESERT Solution Test Strip
Download PDF FDA Summary STERIS Corporation