# K141158: APEX

- Pathway: 510(k) (Traditional)
- Applicant: Incontrol Medical, LLC
- Decided: Nov 26, 2014 after 205 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: 8 generations back to K930530 (1995). 25 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 35 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.

## Most influential descendants
- K142506: TensCare KegelFit (2015), 4 descendants of its own
- K191312: Perfect PFE (2019), 3 descendants of its own
- K150183: ApexM (2015), 3 descendants of its own
- K182022: ApexMV (2019), 1 descendant of its own
- K260178: Pelvic Muscle Trainer (KM510, KM516B) (2026), 0 descendants of its own

## Indications for use
Apex is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support.

Source page: https://510kreport.com/device/K141158
Methodology: https://510kreport.com/methodology