# K201490: Electro Flo 6 Airway Clearance System

- Pathway: 510(k) (Traditional)
- Applicant: Med Systems, Inc.
- Decided: Feb 12, 2021 after 253 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: 8 generations back to K884098 (1988). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173603: Monarch Airway Clearance System, Hill-Rom Holdings, Inc. (2018) Summary page 4.
- K031876: Electro Flo Percussor, Model 5000, Med Systems (2003) Summary page 4.

## Indications for use
The Electro Flo® 6 Airway Clearance System 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 device is intended for home or institutional use by patients weighing at least 23 Kg.

Source page: https://510kreport.com/device/K201490
Methodology: https://510kreport.com/methodology