# K241516: BTL-398

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Feb 10, 2025 after 257 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K930530 (1995). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181497: HPM-6000UF, BTL Industries, Inc. (2018) Summary page 6.

## Indications for use
The device is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

Source page: https://510kreport.com/device/K241516
Methodology: https://510kreport.com/methodology