Atlas FDA

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

Implant Sciences Corp. — Predicate Candidate Screening

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

90 daysmedian FDA review time
203 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K070468IMPLANT SCIENCES CORP. MODEL HDR 4454Implant Sciences Corp.2007-03-23350
K042864IMPLANT SCIENCES CORP, MODEL HDR-4140Implant Sciences Corp.2005-01-06800
K023073SEED LINKImplant Sciences Corp.2003-04-072030
K023242I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILEImplant Sciences Corp.2002-12-04650
K994317I-PLANT, MODEL 3500Implant Sciences Corp.2000-03-21900
K990193IODINE BRACHYTHERAPY SEEDS, MODEL 3000Implant Sciences Corp.1999-05-201190

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