Auris Health, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Auris Health, Inc.” (first 2020, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 117 days. Since 2017 the median was 117 days, against 146 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 117 |
| 2021 | 1 | 57 |
| 2022 | 1 | 205 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 108 |
| 2026 | 1 | 170 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Auris Health, Inc. took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 4 | 4 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 | 1 |
Review panels
Most recent Auris Health, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260382 | MONARCH Platform (MON-000008) | EOQ | 2026-07-25 | 170 |
| K243219 | MONARCH Platform (MON-000008) | EOQ | 2025-01-23 | 108 |
| K213334 | Monarch Platform, Urology | FGB | 2022-04-29 | 205 |
| K211493 | Monarch Platform | EOQ | 2021-07-09 | 57 |
| K193534 | Monarch Platform | EOQ | 2020-04-15 | 117 |
Recalls
8 product recalls in 5 recall events; 7 initiated in the last five years. Most recent: 2026-01-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Auris Health, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06330701: Stone Access and Removal (STAR) Study (Completed, started 2024-01-18)
- NCT05835323: Initial Clinical Experience With the MONARCH Platform, Urology for the Treatment of Kidney Stones (Completed, started 2023-01-11)
- NCT04182815: Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (Completed, started 2019-12-10)
- NCT03727425: Robotic Bronchoscopy for Peripheral Pulmonary Lesions (Completed, started 2018-11-01)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Auris Health, Inc., A Johnson and Johnson Family Company (2 510(k)s)
- Auris Surgical Robotics, Inc. (2 510(k)s)
- Auris Health, Inc., part of Johnson & Johnson MedTech (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Auris Health, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Auris Health, Inc.” (first 2020, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Auris Health, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Auris Health, Inc. is 117 days. Since 2017: 117 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Auris Health, Inc.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 4); FGB (Ureteroscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 5 Auris Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Auris Health, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.