# K173603: Monarch Airway Clearance System

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Holdings, Inc.
- Decided: Oct 24, 2018 after 337 days
- Product code: BYI (Percussor, Powered-Electric)
- Device class: 2
- Regulation: 21 CFR 868.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K884098 (1988). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163378: Monarch Airway Clearance System, Hill-Rom Services Pte, Ltd. (2017) Summary page 4.

## Most influential descendants
- K201490: Electro Flo 6 Airway Clearance System (2021), 0 descendants of its own

## Indications for use
The Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician’s choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The Monarch™ Airway Clearance System is intended to be used in the Home Care environment by patients, 15 years and older.

Source page: https://510kreport.com/device/K173603
Methodology: https://510kreport.com/methodology