Critikon Transcutaneous Gas Monitors
by Critikon Company, LLC 510(k)
Active
510(k) K813347
Overview
The Critikon Transcutaneous Gas Monitors are cutaneous oxygen monitors designed for non-invasive measurement of oxygen (PaO₂) and carbon dioxide (PaCO₂) levels in infants who are not under general gas anesthesia. These devices provide real-time monitoring of arterial blood gas tensions through the skin, aiding in the assessment of respiratory function and metabolic status in pediatric patients.
These reusable medical devices are regulated under FDA 510(k) clearance (K813347) and classified as Class II. They are intended for use in clinical settings such as operating rooms, intensive care units, and pediatric wards. The device requires proper maintenance and calibration to ensure accurate readings. The regulatory submission was reviewed by the Anesthesiology Advisory Committee and granted a Substantially Equivalent (SESE) decision in 1982. No specific MRI safety information is provided.
Critikon Transcutaneous Gas Monitors
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813347 | Date26 Jan 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KLK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2500
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Critikon Company, LLC
Questions
What is the Critikon Transcutaneous Gas Monitor used for?
The Critikon Transcutaneous Gas Monitors are designed for non-invasive measurement of arterial oxygen (PaO₂) and carbon dioxide (PaCO₂) levels in infants who are not under general gas anesthesia. These devices provide real-time monitoring through the skin, helping clinicians assess respiratory function and metabolic status in pediatric patients, particularly in settings like operating rooms, intensive care units, and pediatric wards.
Are the Critikon Transcutaneous Gas Monitors reusable or single-use?
The Critikon Transcutaneous Gas Monitors are reusable medical devices. Like all reusable equipment, they require proper maintenance, cleaning, and calibration to ensure accurate and reliable performance over multiple uses.
What regulatory approval does the Critikon Transcutaneous Gas Monitor hold?
The device holds FDA 510(k) clearance under the reference number K813347, classified as a Class II medical device. It was reviewed by the Anesthesiology Advisory Committee and granted a Substantially Equivalent (SESE) decision in 1982, indicating it meets regulatory standards for safety and effectiveness.
In which clinical settings are these monitors primarily used?
These monitors are intended for use in clinical environments where pediatric patients require continuous respiratory assessment, such as operating rooms, intensive care units (ICUs), and pediatric wards. Their design supports real-time monitoring of arterial blood gas tensions, which is critical for managing infants with respiratory or metabolic concerns.
What maintenance is required to ensure accurate readings?
The device requires proper maintenance and calibration to maintain accuracy. This includes regular cleaning, adherence to manufacturer guidelines for reuse, and periodic checks to confirm sensor functionality. Neglecting maintenance could compromise the reliability of PaO₂ and PaCO₂ measurements, potentially affecting patient care decisions.