510(k) K252805
K252805 is an FDA 510(k) premarket notification submitted by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. for the device "YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)". The FDA issued a decision of Substantially Equivalent on February 17, 2026. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2026
- Date Received
- September 3, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type