Pulse Oximeter CMS50EW
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141362 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulse Oximeter CMS50EW is a non-invasive medical device classified as a pulse oximeter, designed to measure human oxygen saturation (SpO₂) and pulse rate (PR) via photoplethysmographic technology. It employs photoelectric oxyhemoglobin inspection and capacity pulse scanning to provide real-time monitoring of vital signs, aiding in clinical and non-clinical settings for assessing respiratory and circulatory function.
This device is intended for single-use or reusable applications in environments such as hospitals, oxygen bars, community healthcare, and sports physicals. Supplied as a portable unit, it adheres to FDA 510(k) clearance under the Traditional pathway (K141362) and meets MDR requirements. The CMS50EW is non-magnetic and compatible with MRI environments, though specific sterility or storage conditions are not detailed in the specifications.
Frequently asked questions
What clinical settings is the CMS50EW pulse oximeter approved for use in, and how does its portability factor into its versatility?
The CMS50EW is designed for use in a variety of settings, including hospitals, oxygen bars, community healthcare facilities, and even sports physicals. Its portable unit form factor makes it ideal for environments where mobility and ease of use are important, such as non-clinical or mobile healthcare applications. The device’s non-invasive design and real-time monitoring capabilities ensure it can be adapted to diverse settings where respiratory and circulatory function assessment is needed.
Is the CMS50EW pulse oximeter intended for single-use or reusable applications, and what does this mean for its maintenance?
The CMS50EW is explicitly labeled for single-use or reusable applications, meaning it can be used once and discarded or cleaned and reused depending on clinical protocols. For reusable use, proper cleaning and sterilization procedures must be followed to ensure patient safety and device functionality. The manufacturer does not specify sterility or storage conditions in the provided data, so facilities must adhere to their own infection control guidelines.
Can the CMS50EW pulse oximeter be used in an MRI environment, and why is this important for certain patients?
Yes, the CMS50EW is non-magnetic, making it compatible with MRI environments. This is particularly important for patients who require both pulse oximetry monitoring and MRI scans, as traditional pulse oximeters with magnetic components could interfere with imaging or pose safety risks. Its MRI-safe design expands its utility in multi-disciplinary care settings.
What regulatory pathways has the CMS50EW pulse oximeter followed, and how does this affect its availability globally?
The CMS50EW has undergone FDA 510(k) clearance via the Traditional pathway (K141362) and complies with MDR (Medical Device Regulation) requirements, indicating it meets both U.S. and EU regulatory standards. This dual clearance supports its availability in markets where these pathways are recognized, ensuring broader accessibility for clinicians and healthcare providers. The device’s classification under the Cardiovascular advisory committee reflects its role in monitoring vital signs related to respiratory and circulatory function.
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: CMS50EW Pulse Oximeter-CONTEC MEDICAL SYSTEMS CO.,LTD, CONTEC CMS50EW Wireless Bluetooth Pulse Oximeter, Pulse Oximeter-CONTEC Medical Systems Co., Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141362 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- FDA Applicant
- Contec Medical Systems Co.,Ltd
Sources (2)
- FDA 510(k) K141362 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026