Data / Medical devices / United States / Auris Health, Inc
Auris Health, Inc: FDA-registered device maker in Santa Clara, CA, United States, 9 510(k) clearances
Auris Health, Inc is registered with the FDA (registration 3017425975) in Santa Clara, CA, United States. It lists 11 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 25, 2026. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017425975
- FEI number
- 3014447948
- Address
- 5490 Great America Pkwy, Santa Clara, CA, United States, 95054
- Owner or operator
- Auris Health, Inc. (10057462)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 9, 2018
- Registered through
- 2026
- Brand names listed
- Biopsy Forceps - Smooth Cup (MBR-000014), Bronchoscope (flexible or rigid) - Biopsy Forceps - Smooth Cup (MBR-000014);, Bronchoscope (flexible or rigid) - Monarch Platform (MON-000008), Bronchoscope Fluidics Tubing (MBR-000218), Bronchoscope Patient Introducer Kit (MBR-000017), Bronchoscope Patient Introducer Mount (210-000346-00), Bronchoscope Patient Introducer Mount (MON-000006 - 210-000346-00), Bronchoscope Sheath Valve (MBR-000020) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Nephrostomy | LJE | U | Specification developer | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Specification developer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Specification developer | accessdata.fda.gov |
| Integrated Operating Table-Electromechanical Surgical System | SIR | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Kit, Nephroscope | FGA | 2 | Specification developer | accessdata.fda.gov |
| Needle, Catheter | GCB | 1 | Specification developer | accessdata.fda.gov |
| Reprocessed Bronchoscope | QNW | 2 | Specification developer | accessdata.fda.gov |
| System, Irrigation, Urological | LJH | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2026 | K260382 | MONARCH Platform (MON-000008) | EOQ | Substantially Equivalent | Auris Health, Inc. | accessdata.fda.gov |
| July 21, 2026 | DEN250068 | OTTAVA Robotic Surgical System | SIR | Unknown | Auris Health, Inc., part of Johnson & Johnson MedTech | accessdata.fda.gov |
| January 23, 2025 | K243219 | MONARCH Platform (MON-000008) | EOQ | Substantially Equivalent | Auris Health, Inc. | accessdata.fda.gov |
| November 28, 2023 | K231473 | Monarch Bronchoscope | QNW | Substantially Equivalent | Auris Health, Inc., A Johnson and Johnson Family Company | accessdata.fda.gov |
| April 29, 2022 | K213334 | Monarch Platform, Urology | FGB | Substantially Equivalent | Auris Health, Inc. | accessdata.fda.gov |
| July 9, 2021 | K211493 | Monarch Platform | EOQ | Substantially Equivalent | Auris Health, Inc. | accessdata.fda.gov |
| March 11, 2021 | K203614 | Monarch Bronchoscope | QNW | Substantially Equivalent | Auris Health, Inc., A Johnson and Johnson Family Company | accessdata.fda.gov |
| April 15, 2020 | K193534 | Monarch Platform | EOQ | Substantially Equivalent | Auris Health, Inc. | accessdata.fda.gov |
| March 22, 2018 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | EOQ | Substantially Equivalent | Auris Surgical Robotics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 21, 2026 | 98270 | Class II | Ongoing | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB, MON-000008 with software | Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in | accessdata.fda.gov |
| October 18, 2025 | 97781 | Class II | Ongoing | MONARCH Bronchoscope. Model Number: MBR-000211-B | Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. | accessdata.fda.gov |
| August 2, 2024 | 95336 | Class II | Ongoing | Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB. | Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, | accessdata.fda.gov |
| October 18, 2023 | 93320 | Class II | Ongoing | Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. | accessdata.fda.gov |
| April 19, 2019 | 82763 | Class II | Terminated | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | Reports of aspirating biopsy needle breakage | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Exempt
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
- All makers of Integrated Operating Table-Electromechanical Surgical System
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Irrigation, Urological
Updated July 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.