Mini Statco2 Co2 Detector, Model 10-55371
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K031411 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 Mini StatCO₂ CO₂ Detector, Model 10-55371, is a colorimetric device designed for detecting exhaled carbon dioxide (CO₂) in pediatric patients weighing between 1 kg and 15 kg. Classified as a capnograph accessory under the Device Type Capnometer, colorimetric, it visually confirms endotracheal tube placement by indicating the presence of CO₂ in exhaled breath through color changes. This aids in verifying proper intubation during anesthesia and respiratory support procedures. The device operates on a simple, single-use principle, eliminating the need for complex calibration or maintenance.
The Mini StatCO₂ CO₂ Detector is supplied as a single-use, non-sterile device intended for use in clinical settings such as operating rooms, emergency departments, and intensive care units. It connects between an endotracheal tube and a breathing circuit, providing immediate visual feedback via a colorimetric indicator. The device is FDA-cleared under 510(k) K031411 and complies with MDR (Medical Device Regulation) standards. Storage requires protection from moisture and extreme temperatures, and it must be discarded after a single use to ensure accuracy and patient safety.
Frequently asked questions
What pediatric patient weight range is the Mini StatCO₂ CO₂ Detector designed for, and how does this affect its use in clinical settings?
The Mini StatCO₂ CO₂ Detector is specifically designed for pediatric patients weighing between 1 kg and 15 kg, making it suitable for infants and young children. This weight range ensures the device is appropriate for common clinical scenarios like neonatal care, pediatric anesthesia, and emergency intubation, where accurate CO₂ detection is critical for verifying proper endotracheal tube placement.
Is the Mini StatCO₂ CO₂ Detector reusable, and if not, why is single-use recommended?
No, the Mini StatCO₂ CO₂ Detector is intended for single-use only. This design choice eliminates the risk of cross-contamination, ensures consistent performance without degradation from reuse, and maintains the accuracy of the colorimetric indicator. Discarding it after one use aligns with best practices for patient safety and regulatory compliance.
How does the Mini StatCO₂ CO₂ Detector provide feedback on endotracheal tube placement, and where is it typically used in a clinical workflow?
The device detects exhaled CO₂ by connecting between an endotracheal tube and the breathing circuit, where a colorimetric indicator changes color upon exposure to CO₂. This visual confirmation helps clinicians quickly verify correct tube placement during procedures like anesthesia induction or mechanical ventilation. It’s commonly used in operating rooms, emergency departments, and intensive care units where rapid confirmation of intubation is essential.
What storage conditions are required for the Mini StatCO₂ CO₂ Detector, and why are they important?
The device must be stored in a dry environment, protected from moisture and extreme temperatures. These conditions prevent damage to the colorimetric indicator and ensure the detector remains accurate and reliable when needed. Proper storage also extends shelf life and maintains the device’s single-use integrity.
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: MINI Modelle – Gokart Feeling erleben, StatCO2® Mini StatCO2® Neo-StatCO2 - Mercury Medical, MINI Konfigurator: Modelle, Preise & Angebote im Überblick, Mini StatCO2 Carbon Dioxide Detector by Mercury Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K031411 | Class II | Active |
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Manufacturer
- Manufacturer
- Mercury Medical
Sources (2)
- FDA 510(k) K031411 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 18, 2026