510(k) Report

FDA applicant

Ototronix, LLC

St. Paul, MN3 decisions2001–20140 recalls

FDA records 3 decisions for Ototronix, LLC (St. Paul, MN) from 2001 to 2014: 2 510(k) clearances and 1 original PMA approval. Most are in product codes NEA (Cement, Ear, Nose And Throat) and GWN (Nystagmograph). Its devices cite 5 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, dental panel, where it files most

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

FDA decisions per year

1in 2014

2013: 12014: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ototronix, 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?

  • NEACement, Ear, Nose And Throat1decision
  • GWNNystagmograph1decision
  • MPVImplant, Hearing, Active, Middle Ear, Partially Implanted1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K140644ProcemOtotronix, LLC · 2014
  • K130201Nystagram Video Nystagmography SystemOtotronix, LLC · 2013
  • P010023Soundtec Direct SystemOtotronix, LLC · 2001

All 3 as Ototronix, LLC →