YUWELL® Electronic Blood Pressure Monitor (YE630CR)— 510(k) K252779

Clearance details

Applicant

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2025-09-02

Decision date

2026-03-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Zhenjiang, CN

• K261929 — Upper Arm Blood pressure monitor (BP7155D)2026-09-10
• K254000 — Happy Health Blood Pressure Monitor2026-09-03
• K262658 — Automatic Digital Blood Pressure monitor (LD-526)2026-08-31
• K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)2026-08-26
• K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)2026-08-13

• K261571 — Manual Wheelchair (H008, PCK7)2026-08-06
• K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR)2026-02-23
• K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)2026-02-17
• K242736 — Portable Oxygen Concentrator (Spirit-3)2025-06-05
• K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)2025-05-22

Death

3

Injury

169

Malfunction

1,019

Other

2

Total

1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →