Atlas FDA

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

Tanabe U.S.A., Inc. — Predicate Candidate Screening

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

211 daysmedian FDA review time
269 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932368UROPAPER EIKEN 6BTanabe U.S.A., Inc.1994-01-132690
K932366UROPAPER EIKEN HAGTanabe U.S.A., Inc.1993-11-262210
K932365UROPAPER EIKEN AGTanabe U.S.A., Inc.1993-11-262210
K932367UROPAPER EIKEN 8Tanabe U.S.A., Inc.1993-11-162110
K932363UROPAPER EIKEN GKTanabe U.S.A., Inc.1993-11-162110
K931897UROPAPERTanabe U.S.A., Inc.1993-11-162110
K932369UROPAPER EIKEN 7Tanabe U.S.A., Inc.1993-11-162110
K932364UROPAPER EIKEN GPTanabe U.S.A., Inc.1993-11-162110

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