510(k) Report

FDA applicant

Gel-Lite, LLC

Jacksonville, FL1 decision1998–19980 recalls

FDA records 1 decision for Gel-Lite, LLC (Jacksonville, FL) in 1998: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). Its devices cite 1 predicate, 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 and plastic surgery panel, where it files most

How often FDA has decided Gel-Lite, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gel-Lite, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KKXDrape, Surgical, Antimicrobial1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K980210Various Surgical or Patient DrapesGel-Lite, LLC · 19981cites it

What has FDA decided for it lately?

  • K980210Various Surgical or Patient DrapesGel-Lite, LLC · 1998

The one decision as Gel-Lite, LLC →