510(k) Report

FDA applicant

Shikani Medical, LLC

Bonita Springs, FL1 decision2010–20100 recalls

FDA records 1 decision for Shikani Medical, LLC (Bonita Springs, FL) in 2010: 1 510(k) clearance. All are in product code JOH (Tube Tracheostomy And Tube Cuff). 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, anesthesiology panel, where it files most

How often FDA has decided Shikani Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Shikani Medical, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shikani Medical, LLC’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?

  • JOHTube Tracheostomy And Tube Cuff1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K100995Shikani Speaking ValveShikani Medical, LLC · 2010

The one decision as Shikani Medical, LLC →