# K954272: Innova Rectal Stimulaton Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Apr 15, 1996 after 216 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: 1 generation back to K891773 (1989). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910081: TBD, Empi (1991) Summary page 1.
- K940091: Innova Vaginal Emg Sensing Electrode, Empi (1994) Summary page 2.
- K891773: Microgyn II Elec Stim Device Treat of Urin Inconti, Hollister, Inc. (1989) Summary page 1.

## Most influential descendants
- K964577: Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode (199205) (1997), 6 descendants of its own
- K011190: Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System) (2002), 3 descendants of its own
- K020126: Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System) (2002), 2 descendants of its own
- K020952: Surx RF System (2002), 1 descendant of its own
- K042132: Novasys Transurethral RF System (2004), 0 descendants of its own

## Indications for use
The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of urinary incontinence.

Source page: https://510kreport.com/device/K954272
Methodology: https://510kreport.com/methodology