TCO2M Model 818 Monitor

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

Generic Name

MONITOR, CARBON-DIOXIDE, CUTANEOUS

PMA Number

P810022 ↗

510(k) Number

K791152 ↗

FDA Product Code

KLK

Device Class

Class II

Regulation

21 CFR Part 868.2500

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

PMA Supplement

S003

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• What clinical settings is the TCO2M Model 818 Monitor designed for, and how does it differ from similar devices used under general anesthesia?

  The TCO2M Model 818 is specifically designed for use in infants who are *not* under general anesthesia, making it ideal for settings like pediatric wards, intensive care units, and operating rooms where respiratory monitoring is critical but anesthesia is not administered. Unlike monitors intended for anesthetized patients, this device focuses on real-time cutaneous measurement of transcutaneous carbon dioxide (PCO₂) to assess respiratory function and metabolic status in awake or lightly sedated infants.

• Is the TCO2M Model 818 Monitor single-use or reusable, and what maintenance is required?

  The TCO2M Model 818 is a reusable device, meaning it can be used across multiple patients with proper care. However, it requires calibration and maintenance as instructed by the manufacturer to ensure accurate and reliable performance. Regular upkeep is essential to sustain its functionality for continuous monitoring in clinical environments.

• Can this monitor be used in an MRI environment, and if not, what storage guidelines should be followed?

  No, the TCO2M Model 818 is explicitly *not* intended for use in MRI environments due to potential electromagnetic interference or safety risks. To maintain accuracy and reliability, it must be stored according to the manufacturer’s guidelines, which likely include protection from extreme temperatures, humidity, and physical damage, as well as proper handling to prevent contamination or damage to sensitive components.

• What regulatory pathways does the TCO2M Model 818 follow, and how does this affect its use in clinical practice?

  The TCO2M Model 818 has undergone both a Traditional 510(k) clearance (K791152) and a Premarket Approval (PMA, P810022), placing it under FDA Device Class II regulation (868.2500). This means it has been evaluated for safety and effectiveness through rigorous review processes, including advisory committee input from anesthesiology experts. Clinicians can rely on its compliance with these pathways, ensuring it meets established standards for monitoring transcutaneous carbon dioxide in pediatric patients.