Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
510(k) K250179
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK250179 | Date29 Jul 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- MHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Patient Monitor, Physiological (With Arrhythmia Detection or Alarms), designed to continuously monitor vital signs such as ECG, heart rate, blood pressure, SpO₂, and temperature. It provides real-time patient data and alarms for arrhythmias or critical parameter deviations, supporting clinical decision-making in acute and critical care settings.
The monitors are supplied as reusable medical devices, intended for use in hospital wards, intensive care units, and emergency departments. They are classified as Class II devices under FDA regulations and comply with FDA 510(k) and MDR authorisations. Each model (CX10, CX12, CX15, UX10, UX12, UX15) may vary in specific features or configurations, but all adhere to the same regulatory standards for physiological monitoring.
Other devices from Edan Instruments, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these patient monitors designed for single-use or can they be reused in a clinical setting?
The EDAN Instruments Patient Monitors (CX10, CX12, CX15, UX10, UX12, UX15) are explicitly described as reusable medical devices. They are intended for repeated use in hospital wards, intensive care units, and emergency departments, adhering to standard reprocessing protocols for reusable medical equipment.
What types of vital signs can these monitors track, and how do they support clinical decision-making?
These monitors continuously track ECG, heart rate, blood pressure, SpO₂ (oxygen saturation), and temperature. They also feature arrhythmia detection and alarms for critical parameter deviations, providing real-time data to assist clinicians in acute and critical care settings by alerting them to abnormal trends or events.
How do I determine which model (e.g., CX10 vs. UX15) is best suited for my facility’s needs?
While the exact differences between models (CX10, CX12, CX15, UX10, UX12, UX15) aren’t detailed in the provided data, the specific features or configurations may vary between them. The manufacturer’s documentation or a sales representative should clarify which model aligns with your facility’s requirements, such as display size, connectivity options, or additional monitoring capabilities.
What regulatory pathways have these monitors undergone, and how does that affect their use?
The monitors are authorized under FDA 510(k) clearance and comply with MDR (Medical Device Regulation) standards. They are classified as Class II devices under FDA regulations, meaning they undergo rigorous review by the Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness for physiological monitoring in clinical settings.
Are there any specific storage requirements or environmental considerations for these reusable monitors?
While the data does not specify exact storage conditions, reusable medical devices like these typically require clean, dry environments to prevent contamination or damage. Facilities should follow the manufacturer’s reprocessing guidelines, which likely include cleaning, disinfection, and sterilization protocols before reuse, as well as protection from extreme temperatures or humidity.