510(k) Report

FDA applicant

Dukal Corp.

Ronkonkoma, NY20 decisions1993–20260 recalls

FDA records 20 decisions for Dukal Corp. (Ronkonkoma, NY) from 1993 to 2026: 20 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 252 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dukal Corporation”, “Dukal, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Dukal Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 22009: 12012: 12021: 22022: 32024: 12026 (partial year): 1
2007high 3 (2022) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dukal Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dukal Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EFQGauze/Sponge, Internal4decisions
  • FXXMask, Surgical4decisions
  • FRGWrap, Sterilization2decisions
  • FYAGown, Surgical1decision
  • QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection1decision
  • MGPDressing, Wound And Burn, Occlusive1decision

Also: MLY (1), KKX (1), MSH (1), HIB (1), KMJ (1), OXZ (1).

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 252 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp. · 20062cite it
  • K083320Dukal Surgical Drape; Fenestrated Dukal Surgical DrapeDukal Corp. · 20091cites it
  • K020726Dukal Disposable Vaginal Speculum, Small, Medium, and LargeDukal Corp. · 20021cites it
  • K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation · 20221cites it

What has FDA decided for it lately?

  • K252823Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
  • K233262Dukal SMS Sterilization WrapDukal, LLC · 2024
  • K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation · 2022
  • K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation · 2022
  • K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level…Dukal Corporation · 2022
  • K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks…Dukal Corporation · 2021
  • K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear…Dukal Corporation · 2021
  • K113689Dukal Lubricating JellyDukal Corporation · 2012

All 11 as Dukal Corp. →All 7 as Dukal Corporation →All 2 as Dukal, LLC →