Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dukal Corporation · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
236 daysmedian FDA review time
500 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | Dukal Corporation | 2022-03-30 | 236 | 0 |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022-03-29 | 418 | 0 |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile | Dukal Corporation | 2022-03-18 | 500 | 0 |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, | Dukal Corporation | 2021-02-16 | 236 | 0 |
| K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Duka | Dukal Corporation | 2021-02-05 | 252 | 0 |
| K113689 | DUKAL LUBRICATING JELLY | Dukal Corporation | 2012-05-04 | 141 | 0 |
| K070692 | DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK | Dukal Corporation | 2007-05-30 | 78 | 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