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FDA 510(k)

Wrist Blood Pressure Monitor (BPM-W1VL)

K-Number: K253133 · 2026-02-13

ApplicantShenzhen Imdk Medical Technology Co., Ltd.
Decision Date2026-02-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Blood Pressure Monitor (BPM-W1VL) is a medical device manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-13 under approval number K253133. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrist Blood Pressure Monitor (BPM-W1VL)?

Wrist Blood Pressure Monitor (BPM-W1VL) is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K253133.

When was Wrist Blood Pressure Monitor (BPM-W1VL) approved by the FDA?

Wrist Blood Pressure Monitor (BPM-W1VL) received FDA 510(k) clearance on 2026-02-13, under approval number K253133.

What company makes Wrist Blood Pressure Monitor (BPM-W1VL)?

Wrist Blood Pressure Monitor (BPM-W1VL) is manufactured by Shenzhen Imdk Medical Technology Co., Ltd..

What is the FDA product code for Wrist Blood Pressure Monitor (BPM-W1VL)?

The FDA product code for Wrist Blood Pressure Monitor (BPM-W1VL) is DXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Other Devices by Shenzhen Imdk Medical Technology Co., Ltd.

K173123Pulse Oximeter K180419Ultrasonic Doppler (Model YM-2T8) K221979Pulse Oximeter (Model C101A2, C101B1, C101A3) K243118Arm Blood Pressure Monitor (model: BPM-A7VL) K233040EMS/TENS Massager Device K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

View all 7 devices →

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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