K251795 is an FDA 510(k) clearance for the Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753). This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Honsun (Nantong) Co., Ltd. (Nanton, CN). The FDA issued a Cleared decision on October 9, 2025, 119 days after receiving the submission on June 12, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K251795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2025 |
| Decision Date | October 09, 2025 |
| Days to Decision | 119 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |