# K210764: Flyte

- Pathway: 510(k) (Special)
- Applicant: Pelvital USA, Inc.
- Decided: Apr 13, 2021 after 29 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Pelvital FlyteTm System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Source page: https://510kreport.com/device/K210764
Methodology: https://510kreport.com/methodology