# K150180: InTone

- Pathway: 510(k) (Traditional)
- Applicant: Incontrol Medical, LLC
- Decided: Mar 16, 2015 after 48 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: 9 generations back to K930530 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110179: Incontrol, Incontrol Medical, LLC (2012) Summary page 4.
- K134020: Intonemv, Incontrol Medical, LLC (2014) Summary page 4.

## Indications for use
InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence.

Source page: https://510kreport.com/device/K150180
Methodology: https://510kreport.com/methodology