# K050483: Evadri Bladder Control Systems

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Apr 12, 2005 after 47 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: 4 generations back to K930530 (1995). 7 ancestors in all.
37 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961872: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1996) Summary page 1.
- K974048: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1997) Summary page 1.
- K013612: Incare Pelvic Floor Therapy System, Hollister, Inc. (2002) Summary page 1.
- K001515: Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000, The Prometheus Group (2000)
- K023906: Pathway CTS2000 Pelvic Floor Training System, The Prometheus Group (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K930553: Cub Dis Otoacoustic Emissions Test Instrument, Etymotic Research (1993). Our reading of the summary gave K930553, FDA’s number for Cub Dis Otoacoustic Emissions Test Instrument (Etymotic Research). Its FDA name has none of the distinctive words the summary uses for the device it names, “InCare pelvic Floor Therapy System”. Kept off the family tree. Summary page 1.

## 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 evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or pressure biofeedback for the treatment of urinary and fecal (electromyographic biofeedback) incontinence.

Source page: https://510kreport.com/device/K050483
Methodology: https://510kreport.com/methodology