# K150183: ApexM

- Pathway: 510(k) (Traditional)
- Applicant: Incontrol Medical, LLC
- Decided: Apr 9, 2015 after 72 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.
3 later devices descend from it; 2 cite 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)
- K110179: Incontrol, Incontrol Medical, LLC (2012) Summary page 4.
- K141158: APEX, Incontrol Medical, LLC (2014) Summary page 4.

## Most influential descendants
- K182022: ApexMV (2019), 1 descendant of its own
- 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
- K163288: Pelvifine Pelvic Muscle Trainer (2018), 0 descendants of its own

## Indications for use
ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

Source page: https://510kreport.com/device/K150183
Methodology: https://510kreport.com/methodology