Atlas FDA

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

Best Medical International, Inc. · Predicate Candidate Screening

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

53 daysmedian FDA review time
583 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K162499Best Instruminal ApplicatorBest Medical International, Inc.2018-04-135830
K132097BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPYBest Medical International, Inc.2013-09-30840
K061638BEST STRAND AND BEST SPACERBest Medical International, Inc.2006-08-04530
K043117BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKERBest Medical International, Inc.2004-12-09290
K042786BEST MODEL # 81-01 SERIES IR-192 SOURCESBest Medical International, Inc.2004-11-18430
K042586BEST BREAST BRACHYTHERAPY APPLICATORBest Medical International, Inc.2004-11-03420

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