510(k) · Cleared
ClearedIncontrol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incontrol Medical, LLC · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Feb 22, 2012 as substantially equivalent to K080950 (Otto Bock, Austria GmbH, 2009) and 2 other predicates after a 397-day review. Its family tree reaches back 7 generations to 1995. 21 later devices descend from it.
- Decided
- Feb 22, 2012
- Review
- 397 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K930530 (1995). 24 ancestors in all, the oldest K813008 (1981). 21 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 6 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 5 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 4 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 3 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 2 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 1 generation backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- This deviceK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · cites it directly · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
- Descendant · cites it directly · 9 of its ownK141158 APEXIncontrol Medical, LLC · 2014
- Descendant · 2 generations on · 6 of its ownK181497 HPM-6000UFBTL Industries, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK142506 TensCare KegelFitTenscare, Ltd. · 2015
- Descendant · 3 generations on · 3 of its ownK191312 Perfect PFETenscare, Ltd. · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K134020IntonemvIncontrol Medical, LLC · 2014 · cites it directly10descendants
- K141158APEXIncontrol Medical, LLC · 2014 · cites it directly9descendants
- K181497HPM-6000UFBTL Industries, Inc. · 2018 · 2 generations on6descendants
- K142506TensCare KegelFitTenscare, Ltd. · 2015 · 2 generations on4descendants
- K191312Perfect PFETenscare, Ltd. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −6 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −5 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −4 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −3 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −2 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| −1 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| 0 (this device) | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| +1 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| +1 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| +2 | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
| +2 | K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015 | — |
| +3 | K191312 | Perfect PFE | Tenscare, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080950 | Stiwell MED4Summary page 1…Ph: (262) 957-6797 Trade Name: InControl InTone Predicate Device: Otto Bock STIWELL med, K080950 MyoTrac Infiniti, K053434 Hollister evadri, K050483 Common… | 2009 |
| * | K053434 | Myotrac Infiniti Electrical StimulatorSummary page 1…ade Name: InControl InTone Predicate Device: Otto Bock STIWELL med, K080950 MyoTrac Infiniti, K053434 Hollister evadri, K050483 Common Name: Stimulator, Electrical, Non-Impl… | 2006 |
| * | K050483 | Evadri Bladder Control SystemsSummary page 1…Device: Otto Bock STIWELL med, K080950 MyoTrac Infiniti, K053434 Hollister evadri, K050483 Common Name: Stimulator, Electrical, Non-Implantable, for Incontinence ClsiiainNm:Regula -tion… | 2005 |
What descends from it? (21)
See all 217 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 17 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K134020 (Incontrol Medical, LLC, 2014) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K080950.
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. 2012, this device’s year, is highlighted.
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 InControl InTone device is a non-implanted electrical stimulator indicated for the treatment of female urinary incontinence. It applies electrical stimulation to the pelvic floor musculature and surrounding structures. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles and inhibition of the detrusor muscle through reflexive mechanisms. The biofeedback feature can be used for muscle re-education purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110179: Incontrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110179
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