TCPCO2 Monitoring System
PMA P820025
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP820025 | Date18 Apr 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 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- Withdrawn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
- Cardiovascular
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Overview
AI-generated summary, 20 Sep 2026
The TCPCO₂ Monitoring System is a Monitor, Carbon-Dioxide, Cutaneous, designed for non-invasive measurement of transcutaneous carbon dioxide (PCO₂) levels in patients. It operates by applying a sensor to the skin to assess arterial blood gas parameters, particularly useful in critical care settings such as anesthesia and intensive care. This device provides real-time monitoring of PCO₂, aiding in the management of respiratory function and metabolic balance. Its classification under Device Class II reflects its role in high-stakes clinical environments where precise gas monitoring is essential.
The system is intended for use in clinical settings where continuous or intermittent PCO₂ monitoring is required, such as operating rooms, intensive care units, and recovery areas. Supplied as a reusable medical device, it adheres to FDA_PMA authorization (PMA P820025) and regulatory standards outlined in 21 CFR 868.2480, ensuring compliance with safety and performance requirements. The device is not single-use and must be maintained according to manufacturer guidelines. No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Other devices from Narco Scientific
Questions
AI-generated answers, 20 Sep 2026
What clinical settings is the TCPCO₂ Monitoring System primarily designed for, and how does it help in those environments?
The TCPCO₂ Monitoring System is designed for critical care settings like operating rooms, intensive care units, and recovery areas. It provides real-time, non-invasive measurement of transcutaneous carbon dioxide (PCO₂) levels, which helps clinicians manage respiratory function and metabolic balance. This is particularly useful in high-stakes environments where precise monitoring of arterial blood gas parameters is essential.
Is the TCPCO₂ Monitoring System single-use or reusable, and what maintenance does it require?
The TCPCO₂ Monitoring System is a reusable medical device. While it is not intended for single-use, it must be maintained according to the manufacturer’s guidelines to ensure accurate and reliable performance over time. No specific storage conditions or cleaning instructions are detailed in the provided data.
What regulatory approval does the TCPCO₂ Monitoring System hold, and how does this affect its use?
The TCPCO₂ Monitoring System holds FDA Premarket Approval (PMA P820025), which means it has undergone rigorous review to ensure safety and effectiveness for its intended use. This approval reflects its classification under Device Class II, indicating it is intended for use in clinical settings where precise monitoring is critical, such as anesthesia and intensive care.
Does the TCPCO₂ Monitoring System have any specific safety considerations, such as MRI compatibility?
The provided data does not specify any information regarding MRI safety for the TCPCO₂ Monitoring System. Clinicians should follow manufacturer guidelines and local protocols to ensure safe use in environments where MRI equipment is present.