FDA applicant

Auris Health, Inc.

Redwood, CA5 decisions2020–20266 recalls

FDA records 5 decisions for Auris Health, Inc. (Redwood, CA) from 2020 to 2026: 5 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and FGB (Ureteroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 169 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 of them its own earlier devices. 6 recalls are 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.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020high 1 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2026

2020high 3 (2023) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Auris Health, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Auris Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Auris”

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

Auris Health, Inc., A Johnson and Johnson Family Company 2 Auris Surgical Robotics, Inc. 2 Auris Health, Inc., part of Johnson & Johnson MedTech 1

Auris Health, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Auris”