# K972859: Flutter D

- Pathway: 510(k) (Traditional)
- Applicant: Bradstreet Clinical Research Assoc., Inc.
- Decided: Jun 5, 1998 after 305 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 K940986 (1994). 2 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940986: Flutter (R), Varioraw SA (1994) Summary page 1.
- K946083: Flutter (R), Bradstreet Clinical Research Assoc., Inc. (1995) 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
- K203209: AirPhysio Positive Expiratory Pressure (PEP) Device (2021), 1 descendant of its own
- K140772: Aerosure Medic (2014), 1 descendant of its own
- K103176: Frequencer (2011), 1 descendant of its own

## Indications for use
The efficacy of the Flutter®D as a mucus clearance device for cystic fibrosis patients is based on its ability to 1) vibrate the airways (which loosens mucus from the airway walls), 2) intermittently increase endobronchial pressure (to maintain the patency of airways during exhalation, so that mucus does not become trapped as it moves up the airways), and 3) accelerate expiratory airflow (to facilitate the upward movement of mucus through the airways so that it can be more easily coughed out). Flutter®D may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for Positive Expiratory Pressure (PEP) Therapy.

Source page: https://510kreport.com/device/K972859
Methodology: https://510kreport.com/methodology