510(k) Report

FDA applicant

Sklar Corp.

Great Neck, NY2 decisions2009–20100 recalls

FDA records 2 decisions for Sklar Corp. (Great Neck, NY) from 2009 to 2010: 2 510(k) clearances. Most are in product codes KCT (Sterilization Wrap Containers, Trays…) and FYA (Gown, Surgical). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Sklar Corp. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision
  • FYAGown, Surgical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K091720Sklarlite Rigid Sterilization Container SystemSklar Corp. · 20103cite it

What has FDA decided for it lately?

  • K091720Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010
  • K082479Sklar Surgical GownSklar Corp. · 2009

All 2 as Sklar Corp. →