FDA 510(k)

Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)

K-Number: K250548 · 2025-06-26

Decision Date2025-06-26

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) is a medical device manufactured by Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2025-06-26 under approval number K250548. 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 Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)?

Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by Joytech Healthcare Co. , Ltd.. The 510(k) number is K250548.

When was Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) approved by the FDA?

Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) received FDA 510(k) clearance on 2025-06-26, under approval number K250548.

What company makes Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)?

Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) is manufactured by Joytech Healthcare Co. , Ltd..

What is the FDA product code for Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)?

The FDA product code for Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) is DXN.

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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: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by Joytech Healthcare Co. , Ltd.

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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.