Data / Medical devices / United States / Auris Health, Inc.

Auris Health, Inc.: FDA-registered device maker in San Jose, CA, United States, 8 510(k) clearances

Name: Auris Health, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Auris Health, Inc. is registered with the FDA (registration 3023460764) in San Jose, CA, United States. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 25, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3023460764
Address: 170 Baytech Drive, San Jose, CA, United States, 95134
Owner or operator: Auris Health, Inc. (10057462)
Roles: Manufacturer, Repackager or relabeler
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, Repackager or relabeler	accessdata.fda.gov
Catheter, Nephrostomy	LJE	U	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Kit, Nephroscope	FGA	2	Manufacturer	accessdata.fda.gov
Needle, Catheter	GCB	1	Manufacturer	accessdata.fda.gov
Reprocessed Bronchoscope	QNW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Manufacturer	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
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

Compare with other makers

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.