510(k) K242528
- Device
- Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
- Applicant
- Shenzhen Ruiankang Technology Co., Ltd.
- 510(k) number
- K242528
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-10
- Date received
- 2024-08-26
- 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
- No
Applicant Contact#
- Contact
- Xinhua Zhao
- Address
- Floor1 And 2, #8, Zhugushi Chunyang Industrial Park Wulian Community, Longgang St., Longgang District Shenzhen CN 518117 518117
FDA Registration Numbers#
- 3011912849
- 3044174020
- 3001373226
- 3004987887
- 1450057
- 8043510
- 3018940143
- 3015967131
- 3031789039
- 3003981912
- 3029987970
- 3003800159
- 3006950086
- 3003864328
- 3009901017
- 9680548
- 9617476
- 3038259592
- 1523530
- 3032109181
- 3010262192
- 3012840029
- 8022257
- 3012528160
- 9710654
- 3010157426
- 3036999955
- 3043226252
- 8020605
- 3008573045
- 9615817
- 3003703880
- 3005783425
- 3017207990
- 3004918630
- 3017406171
- 3003803088
- 3017520431
- 3017858797
- 3001149827
- 3013920399
- 3009499478
- 3001570235
- 3009551875
- 3010421104
- 3008780388
- 3008365372
- 3042156936
- 3006258337
- 3006537699
- 1062836
- 3017303999
- 1218950
- 3009156722
- 3015489159
- 3014630021
- 3004871905
- 3024790242
- 3007499349
- 3032013079
- 3038878471
- 1423537
- 3006636961
- 3022147580
- 3018008670
- 2648727
- 3016601021
- 3014449259
- 3030447506
- 2011171
- 3012494290
- 3010082909
- 3009155917
- 3011654863
- 8020616
- 3006113127
- 3031158
- 3010395155
- 9611295
Source Documents#
Other 510(k) Records For Product Code DXN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260670 | YUWELL® Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-10-28 |
| 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) | Shenzhen Brav Electronic Technologies Co., Ltd. | 2026-10-01 |
| K261929 | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | 2026-09-10 |
| K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | 2026-09-03 |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | 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) | JOYTECH Healthcare Co., Ltd. | 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) | Joytech Healthcare Co. , Ltd. | 2026-08-13 |
| K261061 | BP Go (BPP-855) | Wellvii, Inc. | 2026-08-13 |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | 2026-07-23 |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | 2026-07-23 |
| K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-18 |
| K260693 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | 2026-06-16 |
| K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | 2026-06-15 |
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-03 |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | 2026-05-20 |