510(k) · Cleared
ClearedEvadri Bladder Control Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Apr 12, 2005 as substantially equivalent to K961872 (Hollister, Inc., 1996) and 4 other predicates after a 47-day review. Its family tree reaches back 4 generations to 1995. 37 later devices descend from it.
- Decided
- Apr 12, 2005
- Review
- 47 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K930530 (1995). 7 ancestors in all. 37 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 3 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 2 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 1 generation backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- This deviceK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- Descendant · cites it directly · 36 of its ownK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- Descendant · 2 generations on · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · cites it directly · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · cites it directly · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
- Descendant · 2 generations on · 9 of its ownK141158 APEXIncontrol Medical, LLC · 2014
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K053434Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006 · cites it directly36descendants
- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · 2 generations on34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · cites it directly21descendants
- K134020IntonemvIncontrol Medical, LLC · 2014 · cites it directly10descendants
- K141158APEXIncontrol Medical, LLC · 2014 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −3 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −2 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −1 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| 0 (this device) | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| +1 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| +2 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +1 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| +1 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| +2 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPI device
- #1 K262353 BTL-299-Fscore 14.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K930553 | FDA’s K930553 is Cub Dis Otoacoustic Emissions Test Instrument 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…2005 2. Name of Device: evadri Bladder Control System 3. Name of Predicate Device(s) InCare pelvic Floor Therapy System ( K9305530/c, K961872, K974048,and K013612) : Pathway CTS 2000 pelvic Floor Training System ( KO01515 and K023906) 4.… | 1993 |
| * | K961872 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 1…2. Name of Device: evadri Bladder Control System 3. Name of Predicate Device(s) InCare pelvic Floor Therapy System ( K9305530/c, K961872, K974048,and K013612) : Pathway CTS 2000 pelvic Floor Training System ( KO01515 and K023906) 4. Description… | 1996 |
| * | K974048 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 1…f Device: evadri Bladder Control System 3. Name of Predicate Device(s) InCare pelvic Floor Therapy System ( K9305530/c, K961872, K974048,and K013612) : Pathway CTS 2000 pelvic Floor Training System ( KO01515 and K023906) 4. Description of Device… | 1997 |
| * | K013612 | Incare Pelvic Floor Therapy SystemSummary page 1…evadri Bladder Control System 3. Name of Predicate Device(s) InCare pelvic Floor Therapy System ( K9305530/c, K961872, K974048,and K013612) : Pathway CTS 2000 pelvic Floor Training System ( KO01515 and K023906) 4. Description of Device… | 2002 |
| * | K001515 | Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000 | 2000 |
| * | K023906 | Pathway CTS2000 Pelvic Floor Training SystemSummary page 1…InCare pelvic Floor Therapy System ( K9305530/c, K961872, K974048,and K013612) : Pathway CTS 2000 pelvic Floor Training System ( KO01515 and K023906) 4. Description of Device The evadri Bladder Control System is an office based instrument that is intended t… | 2003 |
What descends from it? (37)
See all 373 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K053434 (Thought Technology, Ltd., 2006) has gone furthest, with 36 descendants of its own.
- 4 other devices also cite its predicate K961872.
How does its category compare?
All KPI devicesKPI Stimulator, Electrical, Non-Implantable, For Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPI
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KPI
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPI
No recall names KPI since 2007.
Adverse event reports per year · KPI
2in 2024
MAUDE reports naming product code KPI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 3 | 57 | 0 | 0 |
| 2015 | 6 | 260 | 0 | 2 |
| 2016 | 3 | 89 | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 304 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 3 | 217 | 0 | 1 |
| 2022 | 3 | 181 | 0 | 2 |
| 2023 | 3 | 197 | 0 | 6 |
| 2024 | 4 | 172 | 0 | 2 |
| 2025 | 4 | 263 | 0 | 0 |
| 2026 | 7 | 248 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050483: Evadri Bladder Control Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050483
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026