Atlas FDA

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

Shantou Wealy Medical Instrument Co.,Ltd · Predicate Candidate Screening

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

221 daysmedian FDA review time
401 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K222452Disposable Automatically Retractable Safety Syringes (with dShantou Wealy Medical Instrument Co.,Ltd2022-11-231000
K210216Disposable Automatically Retractable Insulin Safety SyringeShantou Wealy Medical Instrument Co.,Ltd2022-03-044010
K203613ENFit Reusable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd2021-08-272600
K203410ENFit Disposable Enteral SyringeShantou Wealy Medical Instrument Co.,Ltd2021-06-282210
K141640AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLEShantou Wealy Medical Instrument Co.,Ltd2014-11-191530
K113587AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)Shantou Wealy Medical Instrument Co.,Ltd2012-02-24810

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