Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Honsun (Nantong) Co., Ltd. · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

195 daysmedian FDA review time
321 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.2026-06-173210
K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LDHonsun (Nantong) Co., Ltd.2026-04-28900
K251795Wrist automatic blood pressure monitor (LD-735, LD-752, LD-7Honsun (Nantong) Co., Ltd.2025-10-091190
K211629Infrared forehead thermometer LD-FT-100BHonsun (Nantong) Co., Ltd.2021-12-081950
K192500Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomaHonsun (Nantong) Co., Ltd.2020-04-062070
K170866Scian Automatic Digital Blood Pressure Monitor, Model: LD-57Honsun (Nantong) Co., Ltd.2018-02-213350
K170466Automatic Blood Pressure Monitor Model LD-518 & LD-537Honsun (Nantong) Co., Ltd.2017-10-272540
K170454Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LDHonsun (Nantong) Co., Ltd.2017-10-252520
K132627AUTOMATIC DIGITAL BLOOD PRESSURE MONITORHonsun (Nantong) Co., Ltd.2013-10-23620
K130925AUTOMATIC BLOOD PRESSURE MONITORHonsun (Nantong) Co., Ltd.2013-09-121620
K131463WRIST AUTOMATIC BLOOD PRESSURE MONITORHonsun (Nantong) Co., Ltd.2013-07-08480
K092245ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100Honsun (Nantong) Co., Ltd.2009-10-28920

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda