FDA.report

510(k) K252501

Device
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
Applicant
Joytech Healthcare Co. , Ltd.
510(k) number
K252501
Product code
DXN
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-28
Date received
2025-08-08
Regulation
870.1130
Classification name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jing Cong
Address
#365, Wuzhou Rd. #502, Shunda Rd. Hangzhou CN 311100 311100

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DXN

510(k)DeviceApplicantDecision date
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K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-23
K253133Wrist Blood Pressure Monitor (BPM-W1VL)Shenzhen Imdk Medical Technology Co., Ltd.2026-02-13
K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)Joytech Healthcare Co. , Ltd.2026-02-13
K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-02-13
K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-01-12
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K251143Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)Ningbo Ranor Medical Science & Technology Co., Ltd.2025-12-19