# Auris Health, Inc.

- Location (FDA's records): Redwood, CA
- FDA decisions: 5 (2020–2026): 5 510(k) clearances
- Product codes: EOQ (4), FGB (1)
- 510(k) review time since 2016: median 117 days, against 169 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Auris Surgical Robotics, Inc.: 1 (https://510kreport.com/company/auris-surgical-robotics)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)

## Firms that cite its devices most
- Auris Health, Inc., A Johnson and Johnson Family Company: 2 (https://510kreport.com/company/auris-health-a-johnson-and-johnson-family)

## Its most-cited devices
- K193534: Monarch Platform (2020), cited by 3
- K243219: MONARCH™ Platform (MON-000008) (2025), cited by 1
- K211493: Monarch Platform (2021), cited by 1

## Recent decisions
- K260382: MONARCH™ Platform (MON-000008) (Jul 25, 2026)
- K243219: MONARCH™ Platform (MON-000008) (Jan 23, 2025)
- K213334: Monarch Platform, Urology (Apr 29, 2022)
- K211493: Monarch Platform (Jul 9, 2021)
- K193534: Monarch Platform (Apr 15, 2020)

Source page: https://510kreport.com/company/auris-health