Model Pm-20(N)(R)CO2 Patient Monitor/Ala

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

510(k) Number

K800869 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• Is this device single-use or reusable, and how does that affect its maintenance requirements?

  The Model PM-20(N)(R)CO₂ Patient Monitor is designed as a reusable medical instrument, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. Since it is reusable, it requires adherence to manufacturer guidelines for cleaning, sterilization (if applicable), and periodic calibration to ensure accurate CO₂ measurement. The reusable nature also means it must be stored in a clean, dry environment when not in use to prevent contamination or damage.

• What clinical setting is this device primarily intended for, and how does it assist clinicians?

  This device is primarily intended for use in operating rooms or anesthesia care areas, where real-time monitoring of exhaled carbon dioxide (CO₂) is critical. It helps clinicians assess respiratory function and ventilation efficacy during anesthesia by providing immediate feedback on CO₂ concentrations. This aids in ensuring proper ventilation, detecting issues like endotracheal tube dislodgment, or assessing the effectiveness of mechanical ventilation.

• What regulatory pathway was followed for FDA clearance, and what does the product code (CCK) indicate?

  The Model PM-20(N)(R)CO₂ received FDA clearance through a 510(k) submission (K800869) under the traditional review pathway, meaning it was compared to a legally marketed predicate device to demonstrate substantial equivalence (SESE). The product code CCK categorizes it under Anesthesiology, specifically as a Gas Analyzer, Carbon-Dioxide, Gaseous-Phase, confirming its role in monitoring exhaled CO₂ during anesthesia procedures.

• How does the device’s design support its intended use in perioperative monitoring?

  The device is a Gas Analyzer, Carbon-Dioxide, Gaseous-Phase, meaning it directly measures exhaled CO₂ gas in real time, which is essential for perioperative monitoring. By continuously analyzing CO₂ concentrations, clinicians can quickly identify ventilation issues (e.g., hypoventilation, hyperventilation, or dislodged tubes) and adjust care accordingly. Its placement in operating rooms or anesthesia areas ensures it aligns with the clinical workflow for anesthesia management.