Auris Health, Inc
Santa Clara, CA, US
Auris Health, Inc appears in FDA device records in Santa Clara, CA. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Auris Health, Inc between 2020 and 2026. The busiest year on record is 2020, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260382 | MONARCH™ Platform (MON-000008) | EOQ | Substantially Equivalent | |
| K243219 | MONARCH™ Platform (MON-000008) | EOQ | Substantially Equivalent | |
| K213334 | Monarch Platform, Urology | FGB | Substantially Equivalent | |
| K211493 | Monarch Platform | EOQ | Substantially Equivalent | |
| K193534 | Monarch Platform | EOQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017425975 | 3014447948 | Auris Health, Inc | 5490 Great America Pkwy, Santa Clara, CA 95054 US | 2026 | and 1 more, listed in full below |
| 3023460764 | 3023460764 | Auris Health, Inc. | 170 Baytech Drive, San Jose, CA 95134 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EOQBronchoscope (Flexible Or Rigid)
- LJECatheter, Nephrostomy
- FFLDislodger, Stone, Basket, Ureteral, Metal
- PUIDrape, Surgical, Exempt
- SIRIntegrated Operating Table-Electromechanical Surgical System
- FGAKit, Nephroscope
- GCBNeedle, Catheter
- QNWReprocessed Bronchoscope
- LJHSystem, Irrigation, Urological
- JAKSystem, X-Ray, Tomography, Computed
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1383-2026 | 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 contact with patient/endotracheal tube. | Class II | Open, Classified | |
| Z-0543-2026 | 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. | Class II | Open, Classified | |
| Z-0052-2025 | Monarch Platform (Urology), REF: MON-000007, MON-000007-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, there is a chance of electrical shock. | Class II | Open, Classified | |
| Z-0051-2025 | 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, there is a chance of electrical shock. | Class II | Open, Classified | |
| Z-0450-2024 | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. | Class II | Open, Classified | |
| Z-0449-2024 | Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. | Class II | Open, Classified | |
| Z-0448-2024 | 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. | Class II | Open, Classified | |
| Z-0025-2020 | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | Reports of aspirating biopsy needle breakage | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain