DXN — System, Measurement, Blood-Pressure, Non-Invasive Class II
FDA product code DXN covers "System, Measurement, Blood-Pressure, Non-Invasive", a Class II medical device regulated under 21 CFR 870.1130. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXN
- Device Class
- Class II
- Regulation Number
- 870.1130
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261929 | Omron Healthcare | Upper Arm Blood pressure monitor (BP7155D) | Sep 10, 2026 |
| K254000 | Happy Health | Happy Health Blood Pressure Monitor | Sep 3, 2026 |
| K262658 | Honsun (Nantong) Co | Automatic Digital Blood Pressure monitor (LD-526) | Aug 31, 2026 |
| K261394 | Joytech Healthcare Co | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286 | Aug 26, 2026 |
| K253425 | Joytech Healthcare Co. | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P, | Aug 13, 2026 |
| K261061 | Wellvii | BP Go (BPP-855) | Aug 13, 2026 |
| K261136 | Guangzhou Daxin Health Technology Co | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Jul 23, 2026 |
| K261082 | Microlife Corporation | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Jul 23, 2026 |
| K253126 | Shenzhen Ziqing Medical Equipment Co | Wrist Blood Pressure Monitor (XW-05) | Jun 18, 2026 |
| K260693 | 80 Beats Medical | VicorderCS (VCS-SYS-1100) | Jun 16, 2026 |
| K253059 | Tournicare Pty | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Jun 15, 2026 |
| K253124 | Shenzhen Ziqing Medical Equipment Co | Upper arm electronic blood pressure monitor (XB-01) | Jun 3, 2026 |
| K253570 | Shenzhen Jamr Technology Co | Blood Pressure Monitor (W06LT) | May 20, 2026 |
| K254048 | Shenzhen Urion Technology Co | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19 | May 14, 2026 |
| K253152 | Biozen | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | May 6, 2026 |
| K252501 | Joytech Healthcare Co. | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, D | Apr 28, 2026 |
| K260260 | Honsun (Nantong) Co | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521 | Apr 28, 2026 |
| K253982 | Beijing Hanvon Health Technology Co | Korotkoff sound blood pressure monitor | Apr 21, 2026 |
| K254225 | Shenzhen Hanhan Technology Co | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH | Apr 1, 2026 |
| K260276 | Shenzhen Aoj Medical Technology Co | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS | Apr 1, 2026 |