Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dukal Corp. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
138 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | Dukal Corp. | 2009-03-06 | 114 | 0 |
| K070407 | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & | Dukal Corp. | 2007-03-26 | 42 | 0 |
| K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL | Dukal Corp. | 2006-09-15 | 74 | 0 |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | Dukal Corp. | 2002-05-15 | 70 | 0 |
| K984564 | ETHYL CHLORIDE DISPENSER | Dukal Corp. | 1999-12-02 | 344 | 0 |
| K970457 | DUKAL ABD COMBINE PAD | Dukal Corp. | 1997-05-08 | 91 | 0 |
| K970455 | DUKAL NON ADHERENT DRESSING | Dukal Corp. | 1997-05-08 | 91 | 0 |
| K955476 | DUKAL TRANSPARENT WOUND DRESSING | Dukal Corp. | 1996-01-18 | 49 | 0 |
| K940440 | DUKAL NON-WOVEN GAUZE | Dukal Corp. | 1994-03-09 | 37 | 0 |
| K936095 | GAUZE SPONGE | Dukal Corp. | 1994-02-02 | 42 | 0 |
| K931005 | DUKAL SKIN CLOSURE STRIP | Dukal Corp. | 1993-07-14 | 138 | 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