FDA applicant

Auris Surgical Robotics, Inc.

San Carlos, CA2 decisions2016–20181 recall

FDA records 2 decisions for Auris Surgical Robotics, Inc. (San Carlos, CA) from 2016 to 2018: 2 510(k) clearances. All are in product code EOQ (Bronchoscope (Flexible Or Rigid)). Its devices cite 5 predicates, 0 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 Surgical Robotics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2019

2016high 1 (2019) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Auris Surgical Robotics, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Auris Surgical Robotics, 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. 5 Auris Health, Inc., A Johnson and Johnson Family Company 2 Auris Health, Inc., part of Johnson & Johnson MedTech 1

Auris Surgical Robotics, Inc.

Which product codes does it file in?

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”