Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Predicate Candidate Screening

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

237 daysmedian FDA review time
535 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.2026-04-022180
K191571UV Radiation Treatment SystemXuzhou Yongkang Electronic Science Technology Co., Ltd.2020-02-062370
K183491Arm Blood Pressure MonitorXuzhou Yongkang Electronic Science Technology Co., Ltd.2019-03-24970
K180314Infrared ThermometerXuzhou Yongkang Electronic Science Technology Co., Ltd.2018-07-111560
K162616Wrist Type Blood Pressure MonitorXuzhou Yongkang Electronic Science Technology Co., Ltd.2018-03-095350
K161938Fingertip Pulse OximeterXuzhou Yongkang Electronic Science Technology Co., Ltd.2017-05-082980

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