M-XX Oxygen Sensors
by International Business Strategies
510(k) K002384
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK002384 | Date15 Dec 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CCL
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1720
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The M-XX Oxygen Sensors are classified as Analyzer, Gas, Oxygen, Gaseous-Phase, designed to measure oxygen concentration in gaseous samples. These devices provide precise monitoring of oxygen levels, critical for applications in anesthesia and respiratory care, where accurate gas analysis is essential for patient safety and treatment efficacy.
These sensors are supplied as reusable medical devices, intended for use in clinical settings such as operating rooms and anesthesia workstations. They are regulated under FDA 510(k) clearance (K002384) and fall under Regulation 868.1720, with a classification of Class II. The devices are associated with the Anesthesiology specialty and reviewed by the Anesthesiology Advisory Committee. No third-party certification is indicated.
Other devices from International Business Strategies
Questions
AI-generated answers, 20 Sep 2026
Are the M-XX Oxygen Sensors designed for single-use or can they be reused in clinical settings?
The M-XX Oxygen Sensors are explicitly described as reusable medical devices, intended for repeated use in clinical environments like operating rooms and anesthesia workstations. Their design supports long-term reliability in monitoring oxygen levels, which is critical for applications in anesthesia and respiratory care.
What types of clinical environments or specialties are these sensors primarily intended for?
These sensors are specifically associated with anesthesiology and are designed for use in clinical settings such as operating rooms and anesthesia workstations. Their purpose is to provide precise oxygen concentration measurements, ensuring patient safety during procedures where accurate gas analysis is essential.
How are the M-XX Oxygen Sensors regulated, and what does that mean for their use in healthcare facilities?
The M-XX Oxygen Sensors are regulated under FDA 510(k) clearance (K002384) and classified as Class II devices under regulation 868.1720. This means they have undergone a review by the Anesthesiology Advisory Committee to demonstrate substantial equivalence to a predicate device, ensuring they meet safety and performance standards for use in clinical settings like operating rooms and anesthesia workstations.
Are there multiple models or sizes available for the M-XX Oxygen Sensors, and if so, how are they differentiated?
The data lists multiple registration numbers (e.g., 3013500228, 3000126629, etc.), which typically correspond to different models or variants of the device. While the exact specifications (e.g., sensor sensitivity, connectivity, or physical dimensions) are not detailed here, these variations likely cater to different clinical workflows or compatibility requirements in anesthesia and respiratory care systems.
What should healthcare facilities consider regarding storage or maintenance of the M-XX Oxygen Sensors?
Since these sensors are reusable, facilities should follow manufacturer guidelines for cleaning, calibration, and maintenance to ensure accurate oxygen readings over time. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, reusable medical devices generally require proper handling to prevent contamination or degradation, particularly in environments where they interface with patient care systems.