FDA applicant

Auris Health, Inc., A Johnson and Johnson Family Company

Redwood, CA2 decisions2021–20231 recall

FDA records 2 decisions for Auris Health, Inc., A Johnson and Johnson Family Company (Redwood, CA) from 2021 to 2023: 2 510(k) clearances. All are in product code QNW (Reprocessed Bronchoscope). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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 Auris Health, Inc., A Johnson and Johnson Family Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2025

2021high 1 (2025) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Auris Health, Inc., A Johnson and Johnson Family Company by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Auris Health, Inc., A Johnson and…’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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Other applicant names beginning “Auris”

FDA records each applicant name separately; these may or may not be the same firm.

Auris Health, Inc. 5 Auris Surgical Robotics, Inc. 2 Auris Health, Inc., part of Johnson & Johnson MedTech 1

Auris Health, Inc., A Johnson and Johnson Family Company

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Auris”