510(k) Report

FDA applicant

Vortek Surgical, LLC

Indianapolis, IN2 decisions2007–20080 recalls

FDA records 2 decisions for Vortek Surgical, LLC (Indianapolis, IN) from 2007 to 2008: 2 510(k) clearances. All are in product code KKX (Drape, Surgical, Antimicrobial). Its devices cite 3 predicates, 1 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 Vortek Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vortek Surgical, 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, Antimicrobial2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070406EndodrapeVortek Surgical, LLC · 20071cites it

What has FDA decided for it lately?

  • K080341Endodrape (TM)Vortek Surgical, LLC · 2008
  • K070406EndodrapeVortek Surgical, LLC · 2007

All 2 as Vortek Surgical, LLC →