YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)— 510(k) K252805
Substantially EquivalentJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
FDA 510(k) clearance K252805 for YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310), Substantially Equivalent on 2026-02-17. Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. Device class: 2.
Summary
Jiangsu Yuyue Medical Equipment & Supply's YUWELL® Finger Pulse Oximeter lists four models: YX105, YX106, YX110, and YX310. It's filed under product code DQA, oximeter, and the record doesn't say how the models differ.
Class II, 21 CFR 870.2700. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Jiangsu Yuyue Medical Equipment & Supply filed from Danyang, China. FDA found it substantially equivalent 167 calendar days after receipt (September 3, 2025 to February 17, 2026).
Clearance details
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Product code
- Product code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danyang, CN
Recent devices under product code DQA
view all- K260490 — Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)
- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
More clearances from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
view allAdverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.