Company ยท US
Dukal Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2026. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EFQ | Gauze/Sponge, Internal | 4 |
| FXX | Mask, Surgical | 4 |
| FRG | Wrap, Sterilization | 2 |
| FPX | Strip, Adhesive, Closure, Skin | 1 |
| FPY | Sheet, Burn | 1 |
| FYA | Gown, Surgical | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KMJ | Lubricant, Patient | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 |
| MLY | Vapocoolant Device | 1 |
| MSH | Respirator, Surgical | 1 |
| OXZ | Pediatric/Child Facemask | 1 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 28, 2026 | K252823 | Dukal Crepe Paper Sterilization Wrap Dukal, LLC | FRG |
| Mar 22, 2024 | K233262 | Dukal SMS Sterilization Wrap Dukal, LLC | FRG |
| Mar 30, 2022 | K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown Dukal Corporation | QPC |
| Mar 29, 2022 | K210321 | Dukal Corporation Level 1 Pediatric Face Mask Dukal Corporation | OXZ |
| Mar 18, 2022 | K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical G Dukal Corporation | FYA |
| Feb 16, 2021 | K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On Dukal Corporation | FXX |
| Feb 5, 2021 | K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Dukal Corporation | FXX |
| May 4, 2012 | K113689 | DUKAL LUBRICATING JELLY Dukal Corporation | KMJ |
| Mar 6, 2009 | K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE Dukal Corp. | KKX |
| May 30, 2007 | K070692 | DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK Dukal Corporation | MSH |
| Mar 26, 2007 | K070407 | DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE Dukal Corp. | FXX |
| Sep 15, 2006 | K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 Dukal Corp. | FXX |
| May 15, 2002 | K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE Dukal Corp. | HIB |
| Dec 2, 1999 | K984564 | ETHYL CHLORIDE DISPENSER Dukal Corp. | MLY |
| May 8, 1997 | K970457 | DUKAL ABD COMBINE PAD Dukal Corp. | EFQ |
| May 8, 1997 | K970455 | DUKAL NON ADHERENT DRESSING Dukal Corp. | EFQ |
| Jan 18, 1996 | K955476 | DUKAL TRANSPARENT WOUND DRESSING Dukal Corp. | MGP |
| Mar 9, 1994 | K940440 | DUKAL NON-WOVEN GAUZE Dukal Corp. | EFQ |
| Feb 2, 1994 | K936095 | GAUZE SPONGE Dukal Corp. | EFQ |
| Jul 14, 1993 | K931005 | DUKAL SKIN CLOSURE STRIP Dukal Corp. | FPX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2017 | Dukal Corp. BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01
Product Usage - May provide a sterile, barrier environment to protect patient from infection. Terminated |
FPY | None listed |