# K203614: Monarch Bronchoscope

- Pathway: 510(k) (Traditional)
- Applicant: Auris Health, Inc., A Johnson and Johnson Family Company
- Decided: Mar 11, 2021 after 91 days
- Product code: QNW (Reprocessed Bronchoscope)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955065 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193534: Monarch Platform, Auris Health, Inc. (2020) Summary page 4.

## Most influential descendants
- K231473: Monarch Bronchoscope (2023), 0 descendants of its own

## 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/K203614
Methodology: https://510kreport.com/methodology