510(k) Report

FDA applicant

Rsq, LLC

Claremont, CA1 decision1998–19980 recalls

FDA records 1 decision for Rsq, LLC (Claremont, CA) in 1998: 1 510(k) clearance. All are in product code LEZ (Aids, Speech Training For The Hearing Impaired…). 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

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

FDA decisions per year

No FDA decision for Rsq, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rsq, 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?

  • LEZAids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)1decision

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.

  • K982396Visivox, Model V-2Rsq, LLC · 19981cites it

What has FDA decided for it lately?

  • K982396Visivox, Model V-2Rsq, LLC · 1998

The one decision as Rsq, LLC →