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ClearMate Isocapnic Ventilation Device

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) DEN170044

by Thornhill Research Inc

Identifiers

510(k) Number
DEN170044 FDA 510(k)
FDA Product Code
QFB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5480 FDA 510(k)
Regulation Number
868.5480 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
DENG FDA 510(k)

The ClearMate Isocapnic Ventilation Device is a Class II medical device designed for controlled ventilation support in clinical settings. It maintains stable carbon dioxide levels (isocapnia) during mechanical ventilation, helping to regulate respiratory function and oxygenation in patients requiring assisted breathing.

This device is supplied as a reusable medical instrument and is intended for use in hospital environments, as indicated by its regulatory classification. It adheres to FDA 510(k) clearance and the Medical Device Directive (MDD), with a product code of QFB. Storage and handling follow standard sterile or non-sterile protocols for reusable medical devices, depending on clinical protocols.

Frequently asked questions

What clinical setting is the ClearMate Isocapnic Ventilation Device primarily intended for, and how does it differ from standard ventilators?

The ClearMate is designed specifically for controlled ventilation support in hospital environments, particularly to maintain stable carbon dioxide levels (isocapnia) during mechanical ventilation. Unlike standard ventilators that focus primarily on airflow and oxygen delivery, this device emphasizes regulating respiratory function and oxygenation by ensuring consistent CO₂ levels, which can be critical for patients with conditions requiring precise respiratory control, such as those in intensive care or post-surgery recovery.

Is the ClearMate a single-use or reusable device, and what does this mean for maintenance and cleaning?

The ClearMate is supplied as a reusable medical instrument, meaning it is intended for repeated use after proper cleaning, disinfection, and sterilization between patients. This requires adherence to standard hospital protocols for reusable medical devices, which typically include thorough cleaning, high-level disinfection, and sterilization (e.g., autoclaving or chemical sterilization) to ensure safety and prevent cross-contamination. Reusability also implies that maintenance, such as calibration and part replacements, may be necessary over time.

How is the ClearMate stored, and are there any special handling instructions for maintaining its performance?

The ClearMate follows standard storage and handling protocols for reusable medical devices, which may involve either sterile or non-sterile preparation depending on clinical protocols. Since it is reusable, storage should occur in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage. If sterilized between uses, it should be stored in a sealed, sterile packaging until ready for use. Always follow manufacturer guidelines and hospital infection control policies to ensure proper functionality and safety.

What regulatory pathways does the ClearMate follow, and how does this affect its availability or use in hospitals?

The ClearMate has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD), indicating it meets regulatory standards for Class II medical devices in the U.S. and EU markets, respectively. This clearance confirms it has been evaluated for safety and effectiveness for its intended use in controlled ventilation support. Hospitals can rely on this regulatory backing to ensure the device adheres to established medical device standards, though local hospital policies and clinical guidelines may still dictate specific protocols for its implementation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thornhill Research Inc
FDA Applicant
Thornhill Research, Inc.

Sources (2)

  • FDA 510(k) DEN170044 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026