Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sybron Endo/Analytic · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031664 | ELEMENTS OBTURATION UNIT | Sybron Endo/Analytic | 2004-04-28 | 335 | 2 |
| K021253 | ULTRASONIC TIPS WITH DIAMOND COATING | Sybron Endo/Analytic | 2002-07-05 | 77 | 0 |
| K021298 | ELEMENTS DIAGNOSTIC UNIT | Sybron Endo/Analytic | 2002-06-19 | 56 | 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