# K243219: MONARCH™ Platform (MON-000008)

- Pathway: 510(k) (Traditional)
- Applicant: Auris Health, Inc.
- Decided: Jan 23, 2025 after 108 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- 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.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211493: Monarch Platform, Auris Health, Inc. (2021) Summary page 5.

## Most influential descendants
- K260382: MONARCH™ Platform (MON-000008) (2026), 0 descendants of its own

## Recalls of this device
- Jan 21, 2026 · Class II · Z-1383-2026: Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to

## Indications for use
The MONARCH™ Bronchoscope and the MONARCH™ Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K243219
Methodology: https://510kreport.com/methodology