Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MXF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
165 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022803 | WATERLASE FOR APICOECTOMY | Biolase Technology, Inc. | 2003-02-03 | 164 | 0 |
| K013908 | WATERLASE MILLENNIUM | Biolase Technology, Inc. | 2002-02-12 | 78 | 0 |
| K012511 | WATERLASE MILLENNIUM | Biolase Technology, Inc. | 2002-01-18 | 165 | 0 |
| K990908 | MILLENNIUM | Endo Technic Corp. | 1999-05-27 | 70 | 0 |
| K990219 | MODIFICATION OF MILLENNIUM | Biolase Technology, Inc. | 1999-02-24 | 33 | 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