# K182022: ApexMV

- Pathway: 510(k) (Traditional)
- Applicant: Incontrol Medical, LLC
- Decided: Mar 15, 2019 after 231 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). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134020: Intonemv, Incontrol Medical, LLC (2014) Summary page 4.
- K150183: ApexM, Incontrol Medical, LLC (2015) Summary page 4.

## Most influential descendants
- K252601: Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) (2026), 0 descendants of its own

## Indications for use
ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women.

Source page: https://510kreport.com/device/K182022
Methodology: https://510kreport.com/methodology