Atlas FDA

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

Samsung Sds Co., Ltd. — Predicate Candidate Screening

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

82 daysmedian FDA review time
126 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002062SAMSUNG 10DR IMPLANT SYSTEMSamsung Sds Co., Ltd.2000-11-091260
K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.1999-10-13840
K992306SAMSUNG RAYPAX DISPLAY WORKSTATIONSamsung Sds Co., Ltd.1999-09-22750
K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.1999-09-13820
K992112SAMSUNG RAYPAX FILM DIGITIZERSamsung Sds Co., Ltd.1999-09-09790
K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.1999-07-06640

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