Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lumen Biomedical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
207 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111987 | FIBERNET EMBOLIC PROTECTION DEVICE | Lumen Biomedical, Inc. | 2011-08-17 | 35 | 0 |
| K082348 | FIBERNET EMBOLIC PROTECTION SYSTEM | Lumen Biomedical, Inc. | 2008-11-18 | 95 | 2 |
| K080901 | LBI EMBOLECTOMY SYSTEM | Lumen Biomedical, Inc. | 2008-10-02 | 185 | 0 |
| K071529 | XTRACT CATHETER SYSTEM | Lumen Biomedical, Inc. | 2007-08-10 | 66 | 1 |
| K053372 | LBI CATHETER SYSTEM | Lumen Biomedical, Inc. | 2006-06-30 | 207 | 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