(105 days)
FDA 510(k) Clearance Letter - Reusable SPO2 Sensor
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January 7, 2026
Shenzhen Best Electronics Co., Ltd.
℅ Lucy Yan
Consultant
Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square
Liuxian Avenue, Xili Town, Nanshan District
Shenzhen, GuangDong 518100
China
Re: K253109
Trade/Device Name: Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulatory Class: Class II
Product Code: DQA
Dated: December 8, 2025
Received: December 8, 2025
Dear Lucy Yan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
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K253109 - Lucy Yan
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).