Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Debusk Knitting Mills, Div. Deroyal Industries · 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) |
|---|---|---|---|---|---|
| K961097 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Debusk Knitting Mills, Div. Deroyal Industries | 1996-06-03 | 76 | 0 |
| K961085 | DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING | Debusk Knitting Mills, Div. Deroyal Industries | 1996-05-21 | 63 | 0 |
| K961087 | DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS | Debusk Knitting Mills, Div. Deroyal Industries | 1996-05-16 | 58 | 0 |
| K954716 | DEROYAL INDUSTRIES INFANT HEEL WARMER | Debusk Knitting Mills, Div. Deroyal Industries | 1996-01-11 | 90 | 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