Wrist Blood Pressure Monitor (BPM-W1VL)— 510(k) K253133
Substantially EquivalentShenzhen Imdk Medical Technology Co., Ltd.
FDA 510(k) clearance K253133 for Wrist Blood Pressure Monitor (BPM-W1VL), Substantially Equivalent on 2026-02-13. Applicant: Shenzhen Imdk Medical Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Imdk Medical Technology's Wrist Blood Pressure Monitor (BPM-W1VL) is filed under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). The record doesn't describe the monitor beyond its name and that code name.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Shenzhen Imdk Medical Technology filed from Shenzhen, China. Review took 141 calendar days (September 25, 2025 to February 13, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Shenzhen Imdk Medical Technology Co., Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- 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)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Shenzhen Imdk Medical Technology Co., Ltd.
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.