Kontron Cutaneous PCO2 Monitor
PMA P810037
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP810037 | Date29 Jan 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- PMA Number
- FDA Product Code
- LKD
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2480
- Advisory Committee
- Anesthesiology
- FDA Decision
- APPR Approved
- PMA Supplement
- S003
Overview
AI-generated summary, 18 Sep 2026
The Kontron Cutaneous PCO₂ Monitor is a Class II medical device designed for measuring transcutaneous partial pressure of carbon dioxide (PCO₂) in patients. It provides real-time monitoring of arterial blood gas levels through non-invasive cutaneous measurement, primarily used in perioperative and critical care settings to assess respiratory function and metabolic status.
This device is intended for single-use applications in clinical environments, including operating rooms and intensive care units. Supplied sterile and regulated under FDA Premarket Approval (PMA P810037), it adheres to regulatory standards outlined in 21 CFR 868.2480. The monitor requires proper calibration and adherence to manufacturer instructions for accurate readings, with no specific MRI safety considerations noted.
Questions
AI-generated answers, 18 Sep 2026
What clinical settings is the Kontron Cutaneous PCO₂ Monitor primarily intended for use in?
The Kontron Cutaneous PCO₂ Monitor is designed for use in perioperative environments, such as operating rooms, and critical care settings like intensive care units. It is intended to provide real-time, non-invasive monitoring of arterial blood gas levels through transcutaneous PCO₂ measurements, helping clinicians assess respiratory function and metabolic status in patients.
Is the Kontron Cutaneous PCO₂ Monitor intended for single-use or reusable applications?
The Kontron Cutaneous PCO₂ Monitor is explicitly intended for single-use applications in clinical environments. This ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for medical device usage in operating rooms and intensive care units.
How is the Kontron Cutaneous PCO₂ Monitor supplied, and what does this mean for its handling?
The device is supplied sterile, which means it is pre-sterilized and packaged to maintain its cleanliness until use. This eliminates the need for additional sterilization procedures by the user, ensuring immediate readiness for clinical application while adhering to infection control protocols.
Does the Kontron Cutaneous PCO₂ Monitor require any special handling or calibration before use?
Yes, the Kontron Cutaneous PCO₂ Monitor requires proper calibration and strict adherence to the manufacturer’s instructions for accurate readings. While the device itself is sterile and ready for single-use, calibration ensures the reliability of the transcutaneous PCO₂ measurements, which is critical for clinical decision-making in perioperative and critical care settings.
Are there any specific storage requirements or considerations for the Kontron Cutaneous PCO₂ Monitor?
The device data does not specify storage requirements, but as a single-use, sterile medical device, it should be stored in its original packaging until use to preserve sterility. Proper storage conditions—such as avoiding extreme temperatures, humidity, or contamination—are generally recommended for all medical devices to maintain their integrity and functionality.