Atlas FDA

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

Contec Medical Systems Co.,Ltd — Predicate Candidate Screening

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

240 daysmedian FDA review time
270 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONContec Medical Systems Co.,Ltd2024-06-142700
K232895B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd2024-05-032280
K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), ColorContec Medical Systems Co.,Ltd2024-05-022260
K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd2022-09-282430
K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Contec Medical Systems Co.,Ltd2021-04-282190
K201980Infrared ThermometerContec Medical Systems Co.,Ltd2020-12-181550
K171360CONTECâ„¢ ElectrocardiographContec Medical Systems Co.,Ltd2018-01-222580
K170856CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd2017-11-172400
K170954Portable ECG MonitorContec Medical Systems Co.,Ltd2017-05-30600
K152863Portable ECG MonitorContec Medical Systems Co.,Ltd2016-06-222660
K141362PULSE OXIMETER CMS50EWContec Medical Systems Co.,Ltd2015-04-233350
K110775ELECTRONIC SPHYGMOMANOMETERContec Medical Systems Co.,Ltd2011-05-13530

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