# K231473: Monarch Bronchoscope

- Pathway: 510(k) (Traditional)
- Applicant: Auris Health, Inc., A Johnson and Johnson Family Company
- Decided: Nov 28, 2023 after 190 days
- Product code: QNW (Reprocessed Bronchoscope)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955065 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203614: Monarch Bronchoscope, Auris Health, Inc., A Johnson and Johnson Family Company (2021) Summary page 4.
- K193534: Monarch Platform, Auris Health, Inc. (2020) Summary page 5.

## Recalls of this device
- Oct 18, 2025 · Class II · Z-0543-2026: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

## Indications for use
The reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures

Source page: https://510kreport.com/device/K231473
Methodology: https://510kreport.com/methodology