FDA applicant

Concha Labs

San Mateo, CA1 decision2024–20240 recalls

FDA records 1 decision for Concha Labs (San Mateo, CA) in 2024: 1 510(k) clearance. All are in product code QUH (Self-Fitting Air-Conduction Hearing Aid, Over…). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Concha Labs by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Concha Labs

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?