Cleared Special

Crosstex VH2O2 Chemical Indicators (K200096) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K200096 · Crosstex International, Inc. (A Cantel Medical Company) · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2021
Decision
546d
Days
Class 2
Risk

K200096 is an FDA 510(k) clearance for the Crosstex VH2O2 Chemical Indicators. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Crosstex International, Inc. (A Cantel Medical Company) (Rush, US). The FDA issued a Cleared decision on July 15, 2021 after a review of 546 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Crosstex International, Inc. (A Cantel Medical Company) devices

Submission Details

510(k) Number K200096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2020
Decision Date July 15, 2021
Days to Decision 546 days
Submission Type Special
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
417d slower than avg
Panel avg: 129d · This submission: 546d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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