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 |
|---|---|---|---|
| K253126 | shenzhen ziqing medical equipment co | Wrist Blood Pressure Monitor (XW-05) | June 18, 2026 |
| K260693 | 80 beats medical | VicorderCS (VCS-SYS-1100) | June 16, 2026 |
| K253059 | tournicare pty | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | June 15, 2026 |
| K253124 | shenzhen ziqing medical equipment co | Upper arm electronic blood pressure monitor (XB-01) | June 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 | April 28, 2026 |
| K260260 | honsun (nantong) co | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521 | April 28, 2026 |
| K253982 | beijing hanvon health technology co | Korotkoff sound blood pressure monitor | April 21, 2026 |
| K254225 | shenzhen hanhan technology co | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH | April 1, 2026 |
| K260276 | shenzhen aoj medical technology co | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS | April 1, 2026 |
| K260273 | shenzhen urion technology co | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B | March 26, 2026 |
| K252779 | jiangsu yuyue medical equipment and supply co | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | March 5, 2026 |
| K253228 | jiangsu yuyue medical equipment and supply co | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | February 23, 2026 |
| K251581 | shenzhen hingmed medical instrument co | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | February 13, 2026 |
| K253133 | shenzhen imdk medical technology co | Wrist Blood Pressure Monitor (BPM-W1VL) | February 13, 2026 |
| K252685 | joytech healthcare co. | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, | February 13, 2026 |
| K251307 | shenzhen hingmed medical instrument co | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | January 12, 2026 |
| K253142 | ningbo ranor medical technology co | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | January 9, 2026 |