Identifiers
- 510(k) Number
- K031814 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 StatCO₂Meter, Model 10-55372, is a colorimetric end-tidal CO₂ detector designed to provide semi-quantitative visualization of carbon dioxide in the patient airway. It functions as a handheld device to assist in confirming proper endotracheal intubation by detecting exhaled CO₂ levels, ensuring respiratory confirmation during critical procedures.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as operating rooms or emergency care. It includes an integrated airway pressure manometer for measuring airway and PEEP (positive end-expiratory pressure) values. Authorized for use in the United States under FDA 510(k) clearance (K031814), it adheres to regulatory standards for anesthesia-related monitoring equipment.
Frequently asked questions
How does the StatCO₂Meter, Model 10-55372, help confirm proper endotracheal intubation during a procedure?
The StatCO₂Meter, Model 10-55372, is a handheld device that visually detects exhaled carbon dioxide (CO₂) in the patient’s airway using a colorimetric method. When properly placed in the trachea, the device shows CO₂ presence, confirming effective intubation. This semi-quantitative feedback helps clinicians quickly verify airway placement, especially critical in emergency or operating room settings.
Is the StatCO₂Meter reusable, and if so, what care or maintenance is required?
Yes, the StatCO₂Meter, Model 10-55372, is designed as a reusable medical instrument. Since it is intended for clinical use in settings like operating rooms or emergency care, it should follow standard reprocessing protocols for reusable anesthesia monitoring equipment, including cleaning, disinfection, and sterilization as per facility guidelines to ensure safety and functionality.
What additional functionality does this device offer beyond CO₂ detection?
Beyond detecting exhaled CO₂ to confirm endotracheal intubation, the StatCO₂Meter includes an integrated airway pressure manometer. This feature allows clinicians to measure airway pressure and positive end-expiratory pressure (PEEP) values, providing real-time monitoring of respiratory mechanics during procedures.
How was the regulatory pathway for this device determined, and what does that mean for its use?
The StatCO₂Meter, Model 10-55372, was reviewed by the FDA’s Anesthesiology Advisory Committee (AN) under a Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the device was deemed comparable to an existing, legally marketed product in terms of technology and performance, allowing it to enter the U.S. market under FDA clearance (K031814). Clinically, this indicates it meets established safety and effectiveness standards for anesthesia-related monitoring.
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. Sources consulted: 510(k) Premarket Notification - FDA, STATCO2METER, MODEL 10-55372 (K031814) — FDA 510(k) | Innolitics, MERCURY MEDICAL FDA Filings - FDA.report, StatCO2® Mini StatCO2® Neo-StatCO2 - Mercury Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031814 | Class II | Active |
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Manufacturer
- Manufacturer
- Mercury Medical
Sources (1)
- FDA 510(k) K031814 24 fields · synced Sep 19, 2026