Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ELE · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210228 | KLS Martin IPS Preprosthetic | KLS-Martin L.P. | 2022-07-08 | 526 | 0 |
| K862926 | SURGICAL VITEX | Jeneric Ind. | 1986-08-29 | 28 | 0 |
| K843557 | K-APATITE 20-40 MESH K-APATITE 40-60 | Katecho, Inc. | 1984-11-30 | 81 | 0 |
| K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | Colmed, Ltd. | 1980-05-28 | 8 | 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