# Auris Health, Inc., A Johnson and Johnson Family Company

- Location (FDA's records): Redwood, CA
- FDA decisions: 2 (2021–2023): 2 510(k) clearances
- Product codes: QNW (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Auris Health, Inc.: 2 (https://510kreport.com/company/auris-health)

## Its most-cited devices
- K203614: Monarch Bronchoscope (2021), cited by 1

## Recent decisions
- K231473: Monarch Bronchoscope (Nov 28, 2023)
- K203614: Monarch Bronchoscope (Mar 11, 2021)

Source page: https://510kreport.com/company/auris-health-a-johnson-and-johnson-family