# K946083: Flutter (R)

- Pathway: 510(k) (Traditional)
- Applicant: Bradstreet Clinical Research Assoc., Inc.
- Decided: Mar 13, 1995 after 90 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
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972859: Flutter D (1998), 9 descendants of its own
- K991561: Roadrunner, Pep Therapy Device (1999), 5 descendants of its own
- 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

## Recalls of this device
- Nov 13, 2014 · Class II · Z-1006-2015: Customer notification that the device may be difficult to open or close.

Source page: https://510kreport.com/device/K946083
Methodology: https://510kreport.com/methodology