Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endotronics, Inc. · 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) |
|---|---|---|---|---|---|
| K875151 | ACUSYST-P/3X | Endotronics, Inc. | 1988-01-12 | 28 | 0 |
| K872086 | ACUSYST-JR | Endotronics, Inc. | 1987-06-15 | 14 | 0 |
| K864334 | ACUSYST-P (CELL CULTURE EQUIPMENT) | Endotronics, Inc. | 1986-11-24 | 20 | 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