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FDA 510(k)

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U

K-Number: K170454 · 2017-10-25

ApplicantHonsun (Nantong) Co., Ltd.
Decision Date2017-10-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U is a medical device manufactured by Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2017-10-25 under approval number K170454. 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 Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U?

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U is a medical device that received FDA 510(k) clearance on 2017-10-25. It is manufactured by Honsun (Nantong) Co., Ltd.. The 510(k) number is K170454.

When was Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U approved by the FDA?

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U received FDA 510(k) clearance on 2017-10-25, under approval number K170454.

What company makes Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U?

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U is manufactured by Honsun (Nantong) Co., Ltd..

What is the FDA product code for Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U?

The FDA product code for Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U 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: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Honsun (Nantong) Co., Ltd.

K170466Automatic Blood Pressure Monitor Model LD-518 & LD-537 K170866Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 K192500Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer K211629Infrared forehead thermometer LD-FT-100B K251795Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)

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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