# K910081: TBD

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jul 15, 1991 after 187 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
No predicates in its family tree.
35 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963222: Microgyn Plus Stimulation Device (1996), 26 descendants of its own
- K023905: Athena Pelvic Muscle Trainer (2003), 14 descendants of its own
- K033256: Athena Pelvic Muscle Trainer II (2003), 13 descendants of its own
- K081480: KEGEL8 Pelvic Exerciser, Model Oph 400 (2008), 12 descendants of its own
- K141643: Yarlap (2015), 10 descendants of its own

Source page: https://510kreport.com/device/K910081
Methodology: https://510kreport.com/methodology