# K173760: Monarch Endoscopy Platform (Monarch Platform)

- Pathway: 510(k) (Traditional)
- Applicant: Auris Surgical Robotics, Inc.
- Decided: Mar 22, 2018 after 101 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: 2 generations back to K955065 (1996). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071530: Karl Storz Video Flexible Video Ent Endoscope System, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 5.
- K162611: PeriFLEX, Spiration, Inc. (2017) Summary page 5.
- K962555: Olympus FB Series Biopsy Forceps, Olympus America, Inc. (1996) Summary page 5.
- K944650: Wang Bronchial Needle Brush, Mill-Rose Laboratory (1994) Summary page 6.

## Most influential descendants
- K193534: Monarch Platform (2020), 5 descendants of its own
- K211493: Monarch Platform (2021), 2 descendants of its own
- K243219: MONARCH™ Platform (MON-000008) (2025), 1 descendant of its own
- K203614: Monarch Bronchoscope (2021), 1 descendant of its own
- K260382: MONARCH™ Platform (MON-000008) (2026), 0 descendants of its own

## Recalls of this device
- Apr 19, 2019 · Class II · Z-0025-2020: Reports of aspirating biopsy needle breakage

## Indications for use
The Monarch Endoscopy Platform (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/K173760
Methodology: https://510kreport.com/methodology