← Back to catalogue

Radiometer TCM-10 Transcutaneous Carbon Dioxide Monitor

FDA PMA

Class II (US FDA PMA)

PMA P800043

by Radiometer America, Inc.

Identity

Trade Name
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO FDA PMA
Generic Name
MONITOR, CARBON-DIOXIDE, CUTANEOUS FDA PMA

Identifiers

PMA Number
P800043 FDA PMA
FDA Product Code
LKD FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 868.2480 FDA PMA
Regulation Number
868.2480 FDA PMA
Advisory Committee
Anesthesiology FDA PMA
FDA Decision
APPR Approved FDA PMA
PMA Supplement
S003 FDA PMA

The Radiometer TCM-10 is a transcutaneous carbon dioxide monitor, classified as a cutaneous carbon dioxide monitoring device. It measures transcutaneous carbon dioxide (TcCO₂) levels non-invasively through the skin, enabling real-time assessment of respiratory function and acid-base balance in clinical settings. This device is designed for use in anesthesiology and critical care environments where continuous monitoring of CO₂ is essential for patient management.

The TCM-10 is supplied as a reusable medical device and is intended for use in controlled clinical environments. It operates under FDA-authorized Premarket Approval (PMA P800043), adhering to regulatory standards for Class II devices. The monitor requires proper calibration and maintenance as outlined in its operational manuals. No specific sterility or MRI safety information is provided in the available data, but its use is governed by the applicable FDA regulations for transcutaneous monitoring devices.

Frequently asked questions

What clinical environments is the Radiometer TCM-10 primarily designed for, and why is it useful there?

The Radiometer TCM-10 is specifically designed for use in anesthesiology and critical care settings, where continuous monitoring of carbon dioxide (CO₂) levels is critical. It provides real-time, non-invasive transcutaneous CO₂ (TcCO₂) measurements through the skin, enabling clinicians to assess respiratory function and acid-base balance. This is particularly valuable during procedures requiring deep sedation, mechanical ventilation, or in intensive care units where rapid changes in CO₂ levels can impact patient stability.

Is the Radiometer TCM-10 a single-use or reusable device, and what maintenance does it require?

The Radiometer TCM-10 is a reusable medical device, intended for use in controlled clinical environments. Like all reusable monitors, it requires regular calibration and maintenance as outlined in the manufacturer’s operational manuals to ensure accurate and reliable performance. Proper upkeep is essential for maintaining measurement precision over repeated use.

What regulatory pathway does the Radiometer TCM-10 follow, and what does that mean for its use?

The Radiometer TCM-10 follows the FDA Premarket Approval (PMA) pathway, with approval under PMA P800043. This means it has undergone rigorous review to demonstrate safety and effectiveness as a Class II transcutaneous carbon dioxide monitor, adhering to FDA regulations for devices in this category. Clinicians can rely on its compliance with established standards for monitoring respiratory function in critical care.

Are there any specific storage requirements or considerations for the Radiometer TCM-10?

While the provided data does not specify sterility or MRI safety details, the device is intended for controlled clinical environments where proper handling and storage are standard practice for reusable medical equipment. It should be stored in a clean, dry location, protected from physical damage, and maintained according to the manufacturer’s guidelines to preserve functionality and accuracy.

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: Radiometer Tcm-10 Transcutaneous Carbon Dioxide Mo, Transcutaneous monitoring solutions - Radiometer, Radiometer Tcm-10 Transcutaneous Carbon Dioxide Mo, Radiometer Transcutaneous Monitoring Solutions: TCM Monitors ... - Manuals+

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Radiometer America, Inc.

Sources (1)

  • FDA PMA P800043 24 fields · synced Sep 20, 2026