# K031876: Electro Flo Percussor, Model 5000

- Pathway: 510(k) (Traditional)
- Applicant: Med Systems
- Decided: Nov 21, 2003 after 157 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: 1 generation back to K801982 (1980). 5 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K802399: Model 2500 Pneumatic Percussor, Medical Equipment Development Co., Inc. (1980) Summary page 1.
- K801982: The Mcshirley Percussor, Mcshirley Products, Inc. (1980) Summary page 1.
- K821265: Pneumopulssor (PPS II), Strom Corp. (1982) Summary page 1.
- K821570: Pneumo Pulssor Iii, Strom Corp. (1982) Summary page 1.
- K813438: Pneumo Pulssor, Strom Corp. (1981) Summary page 1.

## Most influential descendants
- K063645: Frequencer, Model 1001 (2007), 3 descendants of its own
- K100749: Frequencer Model V2X (2010), 2 descendants of its own
- K103176: Frequencer (2011), 1 descendant of its own
- K201490: Electro Flo 6 Airway Clearance System (2021), 0 descendants of its own
- K133057: Vibralung Acoustical Percussor (2014), 0 descendants of its own

## Indications for use
The intended use of the Med Systems Electro Flo Percussor Model 5000 is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ('I (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation. (1). Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. AARC clinical practice guideline: postural drainage therapy. Respiratory Care 1991; 36: 1418 - 1426.

Source page: https://510kreport.com/device/K031876
Methodology: https://510kreport.com/methodology