Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ELS · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
631 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972985 | SPLINT IT | Jeneric/Pentron, Inc. | 1997-09-24 | 44 | 0 |
| K961704 | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | Dentatus USA , Ltd. | 1996-07-26 | 85 | 0 |
| K922673 | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | Glasspan, Inc. | 1994-02-25 | 631 | 0 |
| K834363 | ENDIX RADICULAR BIOCERAMIC PIN | C.B.S. Biotechnics, Inc. | 1984-02-27 | 123 | 0 |
| K811209 | JACOB WIRZ TRANSFIXATION PIN | Colmed, Ltd. | 1981-06-16 | 46 | 0 |
| K801525 | ZEST ENDODONTIC STABILIZER | Zest Anchors, Inc. | 1980-07-21 | 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