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The Tracker / August 2026 / K262658

510(k) cleared

Automatic Digital Blood Pressure monitor (LD-526)

Honsun (Nantong) Co., Ltd. · Aug 31, 2026 · K262658

FDA cleared the Automatic Digital Blood Pressure monitor (LD-526) from Honsun (Nantong) Co., Ltd. on Aug 31, 2026 under K262658, a special 510(k). The device falls under product code DXN, System, Measurement, Blood-Pressure, Non-Invasive, regulated at 21 CFR 870.1130 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 30, 2026. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

Honsun (Nantong) Co., Ltd. has 3 other decisions in the tracker over the last 12 months: 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)).

Questions & Answers

What did FDA clear under K262658?

K262658 is the FDA 510(k) for Automatic Digital Blood Pressure monitor (LD-526), submitted by Honsun (Nantong) Co., Ltd.. FDA's decision date was Aug 31, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Automatic Digital Blood Pressure monitor (LD-526)?

Honsun (Nantong) Co., Ltd., based in Nantong, is the applicant of record for K262658.

How long did the K262658 review take?

FDA received the submission on Jul 30, 2026 and issued its decision on Aug 31, 2026, 32 days later.

← All decisions in August 2026

Sources