YUWELL® Electronic Blood Pressure Monitor (YE650AR)— 510(k) K253228
Substantially EquivalentJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
FDA 510(k) clearance K253228 for YUWELL® Electronic Blood Pressure Monitor (YE650AR), Substantially Equivalent on 2026-02-23. Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. Device class: 2.
Summary
Jiangsu Yuyue Medical Equipment & Supply's YUWELL® Electronic Blood Pressure Monitor (YE650AR) is filed under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). The record doesn't describe the monitor beyond its name and that code name.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Jiangsu Yuyue Medical Equipment & Supply filed from Danyang, China. The substantially equivalent decision came 147 calendar days after receipt (September 29, 2025 to February 23, 2026).
Clearance details
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danyang, CN
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
view all- K261571 — Manual Wheelchair (H008, PCK7)
- K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR)
- K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
- K242736 — Portable Oxygen Concentrator (Spirit-3)
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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.