# K212655: Flyte

- Pathway: 510(k) (Special)
- Applicant: Pelvital USA, Inc.
- Decided: Sep 21, 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K233362: Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (2023), 1 descendant of its own
- K240805: Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (2024), 0 descendants of its own

## Indications for use
The Pelvital 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/K212655
Methodology: https://510kreport.com/methodology