DXN
- Product code
- DXN
- Device name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1130
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 85
- Summaries archived here
- 71 (direct download)
- 510(k) clearances (all years, FDA)
- 1222 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (85)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261394 | 2026-08-26 | JOYTECH Healthcare Co., Ltd. | Arm-type Fully Automatic Digital Blood Pressure Moni… | |
| K261061 | 2026-08-13 | Wellvii, Inc. | BP Go (BPP-855) | |
| K253425 | 2026-08-13 | Joytech Healthcare Co. , Ltd. | Arm-type Fully Automatic Digital Blood Pressure Moni… | |
| K261136 | 2026-07-23 | Guangzhou Daxin Health Technology Co.,… | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,… | |
| K261082 | 2026-07-23 | Microlife Corporation | Microlife Wrist Blood Pressure Monitor , (Model BPHJ… | |
| K253126 | 2026-06-18 | Shenzhen Ziqing Medical Equipment Co.,… | Wrist Blood Pressure Monitor (XW-05) | |
| K260693 | 2026-06-16 | 80 Beats Medical GmbH | VicorderCS (VCS-SYS-1100) | |
| K253059 | 2026-06-15 | Tournicare Pty, Ltd. | Tournicare ARMA Automatic Blood Pressure Monitor (AR… | |
| K253124 | 2026-06-03 | Shenzhen Ziqing Medical Equipment Co.,… | Upper arm electronic blood pressure monitor (XB-01) | |
| K253570 | 2026-05-20 | Shenzhen Jamr Technology Co., Ltd. | Blood Pressure Monitor (W06LT) | |
| K254048 | 2026-05-14 | Shenzhen Urion Technology Co., Ltd. | Wrist Watch Electronic Blood Pressure Monitor (U16H,… | |
| K253152 | 2026-05-06 | Biozen, LLC | BP1000 Ultra-Compact Fingertip Blood Pressure Monito… | FDA |
| K252501 | 2026-04-28 | Joytech Healthcare Co. , Ltd. | Arm-type Fully Automatic Digital Blood Pressure Moni… | |
| K260260 | 2026-04-28 | Honsun (Nantong) Co., Ltd. | Automatic Digital Blood Pressure Monitor (LD-587, LD… | |
| K253982 | 2026-04-21 | Beijing Hanvon Health Technology Co., … | Korotkoff sound blood pressure monitor | FDA |
| K260276 | 2026-04-01 | Shenzhen AOJ Medical Technology Co., L… | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M… | — |
| K254225 | 2026-04-01 | Shenzhen HanHan Technology Co., Ltd. | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-8… | |
| K260273 | 2026-03-26 | Shenzhen Urion Technology Co., Ltd. | Automatic Electronic Blood Pressure Monitor (U90B se… | |
| K252779 | 2026-03-05 | Jiangsu Yuyue Medical Equipment & Supp… | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | |
| K253228 | 2026-02-23 | Jiangsu Yuyue Medical Equipment & Supp… | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | |
| K253133 | 2026-02-13 | Shenzhen Imdk Medical Technology Co., … | Wrist Blood Pressure Monitor (BPM-W1VL) | |
| K251581 | 2026-02-13 | Shenzhen Hingmed Medical Instrument Co… | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | |
| K252685 | 2026-02-13 | Joytech Healthcare Co. , Ltd. | Arm-type Fully Automatic Digital Blood Pressure Moni… | FDA |
| K251307 | 2026-01-12 | Shenzhen Hingmed Medical Instrument Co… | Clinical Automatic Blood Pressure Monitor (DBP-20,DB… | |
| K253142 | 2026-01-09 | Ningbo Ranor Medical Technology Co., L… | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6… | |
| K251143 | 2025-12-19 | Ningbo Ranor Medical Science & Technol… | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,R… | |
| K251331 | 2025-10-27 | Shenzhen Jamr Technology Co., Ltd. | Blood Pressure Monitor (B73, BE23T) | |
| K251795 | 2025-10-09 | Honsun (Nantong) Co., Ltd. | Wrist automatic blood pressure monitor (LD-735, LD-7… | |
| K252769 | 2025-10-02 | Shenzhen Finicare Co., Ltd. | Upper Arm Electronic Blood Pressure Monitor (FC-BP10… | |
| K250231 | 2025-09-03 | Dongguan E-Test Technology Co., Ltd. | Automatic Upper Arm Blood Pressure Monitor (BA-831X… | |
| K251120 | 2025-08-06 | Microlife Corporation | Microlife Upper Arm Automatic Digital Blood Pressure… | |
| K251113 | 2025-08-04 | Andon Health Co, Ltd. | iHealth Compare Wireless Blood Pressure Monitor(BP-3… | |
| K244007 | 2025-07-30 | Cardio Ring Technologies, Inc. Taiwan … | ArteVu | FDA |
| K251102 | 2025-07-16 | Cemho Medical Technology (Guangdong) C… | Automatic Blood Pressure Monitor (CH-S691L, CH-B607,… | |
| K250185 | 2025-07-14 | Jiangxi Aicare Medical Technology Co.,… | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16,… | |
| K250415 | 2025-07-02 | Aktiia SA | G0 Blood Pressure Monitoring System (G0) | |
| K250548 | 2025-06-26 | Joytech Healthcare Co. , Ltd. | Arm-type Fully Automatic Digital Blood Pressure Moni… | |
| K250161 | 2025-05-02 | Shenzhen AOJ Medical Technology Co., L… | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood … | |
| K244000 | 2025-04-30 | Shenzhen AOJ Medical Technology Co., L… | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pres… | |
| K250116 | 2025-04-24 | Shenzhen AOJ Medical Technology Co., L… | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pres… | |
| K250136 | 2025-04-08 | Globalcare Medical Technology Co., Ltd… | Globalcare Blood Pressure Monitor (GUS610) | |
| K250091 | 2025-03-14 | Korot Co., Ltd. | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | |
| K243115 | 2025-02-21 | Shenzhen Urion Technology Co., Ltd. | Upper Arm Electronic Blood Pressure Monitor (U87Y se… | |
| K241578 | 2025-02-19 | Shenzhen Bsx Technology Electronics Co… | Wrist Digital Blood Pressure Monitor (BSX312, BSX313… | |
| K241634 | 2025-02-11 | Guangdong Xinyu Electronic and Technol… | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | |
| K243661 | 2025-02-07 | Hetaida Technology Co., Ltd. | Electronic Blood Pressure Monitor | |
| K242352 | 2025-02-05 | Accurate Meditech, Inc. | Accurate Mini Non-invasive blood pressure monitor (A… | FDA |
| K241590 | 2025-02-03 | Guangdong Xinyu Electronic and Technol… | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, … | FDA |
| K242568 | 2025-01-30 | Shenzhen Zhongkemingwang Telecommunica… | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | |
| K241728 | 2025-01-23 | Murata Vios, Inc. | Vios Monitoring System(TM) Model 2050; Vios Central … | |
| K241066 | 2025-01-14 | Biobeat Technologies , Ltd. | BB-613-BPM | |
| K241431 | 2025-01-13 | Joytech Healthcare Co. , Ltd. | Arm-type Fully Automatic Digital Blood Pressure Moni… | |
| K242528 | 2025-01-10 | Shenzhen Ruiankang Technology Co., Ltd… | Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK2… | |
| K243118 | 2024-11-26 | Shenzhen Imdk Medical Technology Co., … | Arm Blood Pressure Monitor (model: BPM-A7VL) | FDA |
| K241007 | 2024-10-24 | Shenzhen Urion Technology Co., Ltd. | Upper Arm Electronic Blood Pressure Monitor (U86E an… | |
| K242193 | 2024-10-22 | Avita Corporation | Arm Type Blood Pressure Monitor (BPM82) | |
| K241613 | 2024-10-16 | Shenzhen Hbcare Technology Co.,Ltd | Elecrtronic Blood Pressure Monitor (BP-201, BP-202, … | |
| K242721 | 2024-10-04 | Shenzhen Finicare Co., Ltd. | Upper Arm Electronic Blood Pressure Monitor (FC-BP10… | |
| K241351 | 2024-08-21 | Guangdong Transtek Medical Electronics… | Blood Pressure Monitor (TMB-2092-G) | |
| K241129 | 2024-07-03 | Shenzhen Goodlymed Technology Co., Ltd… | Upper Arm Electronic Blood Pressure Monitor | |
| K240729 | 2024-06-14 | Shenzhen Pango Medical Electronics Co.… | Electronic Blood Pressure Monitor (Model: PG-800B30,… | |
| K240832 | 2024-06-07 | Guangdong Transtek Medical Electronics… | Blood Pressure Monitor (BBZ32-AA01) | |
| K240254 | 2024-05-31 | Guangdong Transtek Medical Electronics… | Blood Pressure Monitor (TMB-2296-BT) | |
| K240102 | 2024-04-29 | Guangdong Transtek Medical Electronics… | Blood Pressure Monitor (TMB-2287-B) | |
| K234041 | 2024-04-22 | Andon Health Co, Ltd. | Fully Automatic Electronic Blood Pressure Monitor (K… | |
| K231984 | 2024-03-26 | Shenzhen Hingmed Medical Instrument Co… | Clinical Automatic Blood Pressure Monitor (DBP-01P,D… | |
| K233146 | 2024-03-19 | Shenzhen Jamr Technology Co., Ltd. | Blood Pressure Monitor | — |
| K233799 | 2024-03-15 | Shenzhen Yuezhongxing Technology Co., … | Wrist Blood Pressure Monitor (222); Wrist Blood Pres… | |
| K231303 | 2024-01-26 | Joytech Healthcare Co. , Ltd. | Arm-type Fully Automatic Digital Blood Pressure Moni… | |
| K230996 | 2024-01-04 | Pursuant Health | Pursuant Health Kiosk (G1.D5) | — |
| K233130 | 2023-12-20 | Guangdong Transtek Medical Electronics… | Blood Pressure Monitor | |
| K231478 | 2023-12-15 | Wenzhou Yosun Medical Technology Co.,L… | Digital Blood Pressure Monitor (Model: YB-800) | FDA |
| K232815 | 2023-12-11 | Zhuhai Yueja Medical Device Technology… | Wrist Blood Pressure Monitor | |
| K232053 | 2023-12-08 | Nanowear, Inc. | SimpleSense-BP, SimpleSense-BP Software Application | |
| K223170 | 2023-12-05 | Hetaida Technology Co., Ltd. | Electronic Blood Pressure Monitor, model: HTD6602US | |
| K232814 | 2023-12-05 | Zhuhai Yueja Medical Device Technology… | Electronic Blood Pressure Monitor | |
| K232713 | 2023-11-28 | Guangdong Transtek Medical Electronics… | Blood Pressure Monitor | |
| K231250 | 2023-11-28 | Guangdong Genial Technology Co., Ltd. | Digital Blood Pressure Monitor | — |
| K231245 | 2023-11-22 | Guangdong Genial Technology Co., Ltd. | Digital Blood Pressure Monitor (Arm Type) | — |
| K232621 | 2023-11-22 | Guangdong Transtek Medical Electronics… | Blood pressure monitor | |
| K231310 | 2023-10-27 | Shenzhen Jumper Medical Equipment Co.,… | Electronic Blood Pressure Monitor | |
| K230919 | 2023-10-24 | Edwards Lifesciences, LLC | Acumen IQ finger cuff | |
| K231050 | 2023-10-11 | Alicn Medical Shenzhen, Inc. | Arm Blood Pressure Monitor | — |
| K223873 | 2023-09-29 | Pyrames, Inc. | Boppli Infant Blood Pressure Monitor | |
| K231367 | 2023-09-18 | Shenzhen Finicare Co., Ltd. | Wrist Electronic Blood Pressure Monitor(Model FC-BP2… |
Official FDA classification page: DXN
Classification and pathway per current FDA publications. Data from openFDA (CC0).