Automatic Digital Blood Pressure monitor (LD-526)— 510(k) K262658
Substantially EquivalentHonsun (Nantong) Co., Ltd.
FDA 510(k) clearance K262658 for Automatic Digital Blood Pressure monitor (LD-526), Substantially Equivalent on 2026-08-31. Applicant: Honsun (Nantong) Co., Ltd.. Device class: 2.
Summary
Honsun (Nantong) filed an Automatic Digital Blood Pressure monitor, model LD-526, under product code DXN, non-invasive blood-pressure measurement systems. The device name is generic, and the record has no other description.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel. The submission type is Special 510(k).
The applicant filed from Nantong, China. FDA found it substantially equivalent 32 calendar days after receipt (July 30 to August 31, 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
- K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
More clearances from Honsun (Nantong) Co., Ltd.
view all- K252399 — Portable Oxygen Concentrator
- K260260 — Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
- 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
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.