Cutaneous Gas Monitor

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Cutanious Gas Monitor

Generic Name

MONITOR, CARBON-DIOXIDE, CUTANEOUS

PMA Number

P830008 ↗

FDA Product Code

LKD

Device Class

Class II

Regulation

21 CFR Part 868.2480

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S003

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• What clinical settings is the Cutaneous Gas Monitor primarily used in, and how does it help clinicians?

  The Cutaneous Gas Monitor is designed for use in anesthesiology and cardiovascular settings, such as operating rooms and intensive care units. It measures cutaneous carbon dioxide tension (PCO₂) non-invasively to provide real-time feedback on tissue gas exchange. Clinicians use this data to assess perfusion and metabolic function, ensuring better monitoring of patient health during critical procedures.

• Is the Cutaneous Gas Monitor a single-use device, or can it be reused in a clinical setting?

  The Cutaneous Gas Monitor is intended for reuse in controlled clinical environments. Since it is not labeled as single-use, it must be properly cleaned, disinfected, and maintained according to manufacturer guidelines and facility protocols to ensure safety and accuracy during repeated use.

• What regulatory approval does the Cutaneous Gas Monitor hold, and how does that affect its use?

  The device holds FDA PMA approval (P830008) and subsequent supplements, classifying it as a Class II medical device under FDA regulation 868.2480. This approval ensures it meets established safety and performance standards for non-invasive monitoring of cutaneous CO₂ tension, allowing its use in clinical settings where tissue perfusion and metabolic assessment are critical.

• Are there any specific storage or maintenance requirements for the Cutaneous Gas Monitor?

  While the provided data does not specify sterility or MRI safety details, the device is intended for reuse in controlled environments like operating rooms or ICUs. Standard clinical practice dictates adherence to facility protocols for cleaning, disinfection, and storage to maintain its functionality and prevent contamination. Always follow the manufacturer’s guidelines for proper maintenance.