Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LYS · 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) |
|---|---|---|---|---|---|
| K883183 | TRACER BONE MILL | De Medica Mfg., Inc. | 1988-10-12 | 76 | 0 |
| K860356 | ORTHOBLEND POWERED BONE MILL | Zimmer, Inc. | 1986-07-08 | 159 | 0 |
| K861164 | OSTEOMILL BONE GRINDER | Biodynamic Technologies, Inc. | 1986-05-02 | 35 | 0 |
| K860016 | AESCULAP BONE MILL | Aesculap Instruments Corp. | 1986-03-19 | 75 | 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