Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)— 510(k) K260260
Substantially EquivalentHonsun (Nantong) Co., Ltd.
FDA 510(k) clearance K260260 for Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569), Substantially Equivalent on 2026-04-28. Applicant: Honsun (Nantong) Co., Ltd.. Device class: 2.
Summary
The Automatic Digital Blood Pressure Monitor from Honsun (Nantong) Co., Ltd. is filed under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). The name lists eight model numbers: LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572, and LD-569.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).
Honsun filed from Nantong, China. The decision came 90 calendar days after FDA received it (January 28 to April 28, 2026).
Clearance details
- Applicant
- Honsun (Nantong) 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
- Special
- Location
- Nantong, 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 Honsun (Nantong) Co., Ltd.
view all- K252399 — Portable Oxygen Concentrator
- K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
- K211629 — Infrared forehead thermometer LD-FT-100B
- K192500 — Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
- K170866 — Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
Adverse 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.