Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endomedics, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831792 | SELF-ALIGNING ACETABULAR COMPONENT | Endomedics, Inc. | 1984-09-20 | 475 | 0 |
| K842202 | NEW JERSEY ACETABULAR COMPONENT & | Endomedics, Inc. | 1984-07-20 | 46 | 0 |
| K842234 | NEW JERSEY FEMORAL STEM | Endomedics, Inc. | 1984-07-20 | 45 | 3 |
| K842233 | NEW JERSEY FEMORAL RESURFACING COMPONENT | Endomedics, Inc. | 1984-07-20 | 45 | 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