Reusable and Disposable SpO2 Sensors
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201360 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 device is a Pulse Oximeter Sensor (DQA), designed for non-invasive measurement of arterial oxygen saturation (SpO₂) and pulse rate. It operates by transmitting light through a patient’s fingertip, toe, or earlobe to detect hemoglobin oxygenation levels, enabling real-time monitoring of respiratory and circulatory function. Available in both reusable and single-use variants, it supports clinical applications in patient care settings, including intensive care, operating rooms, and emergency departments. Compliance with FDA and MDR regulatory standards ensures its suitability for medical use in these environments.
These sensors are supplied sterile (disposable) or non-sterile (reusable) and must be handled according to facility protocols. The reusable type requires cleaning and disinfection between uses, while the disposable variant is intended for single-patient use only. Both variants are non-MRI compatible and must be stored in their original packaging to preserve functionality. Authorized under FDA 510(k) clearance (K201360) and MDR compliance, they are classified under the Product Code DQA for pulse oximetry devices.
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: Xinkang Medical Instrument Co.,Ltd, Xinkang Medical Instrument Co.,Ltd, Reusable and Disposable SpO2 Sensors (K201360) - Innolitics
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 | K201360 | Class II | Active |
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Manufacturer
- Manufacturer
- Xinkang Medical Instrument Co. , Ltd.
Sources (2)
- FDA 510(k) K201360 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026