Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biolucent, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
86 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070659 | BIOLUCENT APPLICATOR KIT | Biolucent, Inc. | 2007-04-04 | 26 | 0 |
| K062830 | BIOLUCENT APPLICATOR KIT | Biolucent, Inc. | 2006-10-20 | 30 | 0 |
| K062141 | MAMMOPAD RADIOLUCENT CUSHION | Biolucent, Inc. | 2006-09-13 | 48 | 0 |
| K061241 | BIOLUCENT APPLICATOR, MODEL RTA-XX | Biolucent, Inc. | 2006-07-28 | 86 | 0 |
| K053595 | CURAY CUSTOM SEED ARRAY | Biolucent, Inc. | 2006-02-28 | 67 | 0 |
| K003795 | BIOLUCENT MAMMOGRAPHY CUSHION | Biolucent, Inc. | 2001-02-14 | 68 | 0 |
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