Litton Transcutaneous CO2 System
PMA P850087
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP850087 | Date14 Nov 1986 | 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- Withdrawn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
- Anesthesiology
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Normal 180 Day Track)
Overview
AI-generated summary, 20 Sep 2026
The Litton Transcutaneous CO₂ System is a Monitor, Carbon-Dioxide, Cutaneous, classified under FDA regulation 868.2480. This device measures transcutaneous carbon dioxide (CO₂) levels through the skin, providing real-time monitoring of arterial CO₂ tension (PaCO₂) in clinical settings. It is designed for use in anesthesiology and critical care environments where continuous respiratory monitoring is essential. The system is intended for non-invasive assessment of ventilation and acid-base balance in patients.
The device is supplied as a reusable medical instrument, requiring calibration and maintenance per manufacturer guidelines. It is intended for use in controlled clinical settings such as operating rooms, intensive care units, and recovery areas. The system operates under FDA-authorized Premarket Approval (PMA P850087), with no explicit sterility requirements stated for reusable components. Compliance with MRI safety standards is not referenced in the available data. Storage conditions are unspecified but must adhere to manufacturer recommendations to ensure accurate readings and device longevity.