Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xtal Corp. — 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) |
|---|---|---|---|---|---|
| K861163 | XTAL X-800 SHADOWGRAPH | Xtal Corp. | 1986-05-06 | 39 | 0 |
| K853855 | XTAL X-150 OPERATING MICROSCOPE | Xtal Corp. | 1985-10-15 | 29 | 0 |
| K850049 | KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA | Xtal Corp. | 1985-03-06 | 57 | 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