# Dukal Corp.

- Location (FDA's records): Ronkonkoma, NY
- FDA decisions: 20 (1993–2026): 20 510(k) clearances
- Names in FDA's records: Dukal Corp. (11); Dukal Corporation (7); Dukal, LLC (2)
- Product codes: EFQ (4), FXX (4), FRG (2), FYA (1), QPC (1), MGP (1), MLY (1), KKX (1), MSH (1), HIB (1), KMJ (1), OXZ (1)
- 510(k) review time since 2016: median 252 days, against 177 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cardinal Health200, LLC: 2 (https://510kreport.com/company/cardinal-health200)
- A.R. Medicom, Inc.: 2 (https://510kreport.com/company/ar-medicom)
- Xuchang Zhengde Environstar Medical Products Co., Ltd.: 1 (https://510kreport.com/company/xuchang-zhengde-environstar-medical-products)
- San-M Package Co., Ltd.: 1 (https://510kreport.com/company/san-m-package)
- Valumax Intl., Inc.: 1 (https://510kreport.com/company/valumax-intl)
- Dynarex Corp.: 1 (https://510kreport.com/company/dynarex)
- Kimberly-Clark Corp.: 1 (https://510kreport.com/company/kimberly-clark)
- Kimberly-Clark Health Care: 1 (https://510kreport.com/company/kimberly-clark-health-care)

## Firms that cite its devices most
- Dynarex Corp.: 1 (https://510kreport.com/company/dynarex)
- Primed Medical Products, Inc.: 1 (https://510kreport.com/company/primed-medical-products)
- Shanghai Neo-Medical Import & Export Co., Ltd.: 1 (https://510kreport.com/company/shanghai-neo-medical-import-export)
- Griffith-Lucas, LLC: 1 (https://510kreport.com/company/griffith-lucas)

## Its most-cited devices
- K061864: Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560 (2006), cited by 2
- K083320: Dukal Surgical Drape; Fenestrated Dukal Surgical Drape (2009), cited by 1
- K020726: Dukal Disposable Vaginal Speculum, Small, Medium, and Large (2002), cited by 1
- K210321: Dukal Corporation Level 1 Pediatric Face Mask (2022), cited by 1

## Recent decisions
- K252823: Dukal Crepe Paper Sterilization Wrap (May 28, 2026)
- K233262: Dukal SMS Sterilization Wrap (Mar 22, 2024)
- K212464: Dukal Corporation AAMI Level 4 Open-Back Protective Gown (Mar 30, 2022)
- K210321: Dukal Corporation Level 1 Pediatric Face Mask (Mar 29, 2022)
- 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 (Mar 18, 2022)
- K201732: Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On (Feb 16, 2021)
- 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 (Feb 5, 2021)
- K113689: Dukal Lubricating Jelly (May 4, 2012)

Source page: https://510kreport.com/company/dukal