Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Debusk Technology Corp. · 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) |
|---|---|---|---|---|---|
| K962290 | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER | Debusk Technology Corp. | 1996-07-03 | 19 | 0 |
| K941250 | TROCAR AND CANNULA | Debusk Technology Corp. | 1994-05-06 | 52 | 0 |
| K940299 | ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUA | Debusk Technology Corp. | 1994-05-02 | 101 | 0 |
| K940909 | ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE B | Debusk Technology Corp. | 1994-03-30 | 35 | 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