Dukal Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Dukal Corp.” (first 1993, latest 2026), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 126 days. Since 2017 the median was 252 days, against 156 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 141 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 244 |
| 2022 | 3 | 418 |
| 2023 | 0 | — |
| 2024 | 1 | 175 |
| 2025 | 0 | — |
| 2026 | 1 | 266 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dukal Corp. took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 4 | 4 |
| FXX | Mask, Surgical | 4 | 4 |
| FRG | Wrap, Sterilization | 2 | 2 |
| FPX | Strip, Adhesive, Closure, Skin | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KMJ | Lubricant, Patient | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
| MLY | Vapocoolant Device | 1 | 1 |
Plus 3 more product codes.
Review panels
- General Hospital (12)
- General and Plastic Surgery (6)
- Obstetrics and Gynecology (1)
- Physical Medicine (1)
Most recent Dukal Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252823 | Dukal Crepe Paper Sterilization Wrap | FRG | 2026-05-28 | 266 |
| K233262 | Dukal SMS Sterilization Wrap | FRG | 2024-03-22 | 175 |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | QPC | 2022-03-30 | 236 |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | OXZ | 2022-03-29 | 418 |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown | FYA | 2022-03-18 | 500 |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On | FXX | 2021-02-16 | 236 |
| K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons | FXX | 2021-02-05 | 252 |
| K113689 | DUKAL LUBRICATING JELLY | KMJ | 2012-05-04 | 141 |
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | KKX | 2009-03-06 | 114 |
| K070692 | DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK | MSH | 2007-05-30 | 78 |
10 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-06-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dukal Corp.?
FDA lists 20 510(k) clearances under the applicant name “Dukal Corp.” (first 1993, latest 2026), across 13 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dukal Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dukal Corp. is 126 days. Since 2017: 252 days, versus 156 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dukal Corp.?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 4); FXX (Mask, Surgical, 4); FRG (Wrap, Sterilization, 2).
Next steps
- See all 20 Dukal Corp. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Dukal Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.