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Mercury Medical Statco2 End Tidal Co2 Detector, Model 10-55370

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K021576

by Mercury Medical

Identifiers

510(k) Number
K021576 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The STATCO₂ End Tidal CO₂ Detector, Model 10-55370, is a capnograph designed to measure and display end-tidal carbon dioxide (CO₂) levels in real time. It is used primarily in anesthesia to monitor respiratory function, ensuring proper ventilation and detecting potential complications such as hypoventilation or hyperventilation during surgical procedures.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as operating rooms and intensive care units. It requires no sterility at point of use but may be sterilized for reuse as per manufacturer guidelines. The device is approved under FDA 510K and MDR regulations, with a product code of CCK, and is regulated under the Anesthesiology advisory committee classification.

Frequently asked questions

What clinical setting is the STATCO₂ End Tidal CO₂ Detector primarily used in, and why is it important there?

The STATCO₂ End Tidal CO₂ Detector is primarily designed for use in operating rooms and intensive care units. It monitors end-tidal CO₂ levels in real time to ensure proper ventilation during anesthesia, helping clinicians detect complications like hypoventilation or hyperventilation early. This is critical for patient safety during surgical procedures and critical care.

Is this device single-use or reusable, and what does that mean for its maintenance?

The STATCO₂ End Tidal CO₂ Detector is a reusable medical instrument. This means it can be sterilized and used multiple times after proper cleaning and maintenance, following the manufacturer’s guidelines. Unlike single-use devices, it requires periodic disinfection and sterilization to ensure reliability and safety across procedures.

Does this device require sterilization before use, and if so, what are the key considerations?

The device does not require sterility at the point of use but is intended to be sterilized for reuse. Sterilization must follow the manufacturer’s recommended protocols to maintain performance and safety. Proper sterilization is essential to prevent cross-contamination between patients and ensure accurate CO₂ monitoring.

How is this device regulated, and what does that mean for its use in clinical practice?

The STATCO₂ End Tidal CO₂ Detector is regulated under FDA 510K clearance and the EU’s MDR (Medical Device Regulation). This means it has undergone evaluation by regulatory authorities to confirm its safety and effectiveness for measuring end-tidal CO₂ in anesthesia settings. Clinicians can rely on its compliance with these standards for reliable monitoring during procedures.

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

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mercury Medical

Sources (2)

  • FDA 510(k) K021576 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026