# K994109: Detrusan 500

- Pathway: 510(k) (Traditional)
- Applicant: Innovamed USA, Inc.
- Decided: Aug 3, 2000 after 241 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.
37 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K053434: Myotrac Infiniti Electrical Stimulator (2006), 36 descendants of its own
- K080950: Stiwell MED4 (2009), 34 descendants of its own
- K110179: Incontrol (2012), 21 descendants of its own
- K134020: Intonemv (2014), 10 descendants of its own
- K141158: APEX (2014), 9 descendants of its own

## Indications for use
The Detrusan 500 Incontinence Treatment System is indicated for acute, ongoing-or chronic treatment of Urge, Stress, or Mixed Urinary Incontinence. The System is indicated to improve urethral sphincter closure, strengthen of the pelvic floor-and inhibition of the detruser muscle through reflexive mechanisms.

Source page: https://510kreport.com/device/K994109
Methodology: https://510kreport.com/methodology