# K163378: Monarch Airway Clearance System

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Services Pte, Ltd.
- Decided: Mar 17, 2017 after 106 days
- Product code: BYI (Percussor, Powered-Electric)
- Device class: 2
- Regulation: 21 CFR 868.5665
- 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: 6 generations back to K884098 (1988). 6 ancestors in all.
2 later devices descend 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)
- K142482: The Vest Airway Clearance System, Hill-Rom Services Private Limited (2015) Summary page 4.

## Most influential descendants
- K173603: Monarch Airway Clearance System (2018), 1 descendant of its own
- K201490: Electro Flo 6 Airway Clearance System (2021), 0 descendants of its own

## Recalls of this device
- Sep 15, 2017 · Class II · Z-0192-2018: Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they

## 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/K163378
Methodology: https://510kreport.com/methodology