510(k) · Cleared
ClearedAPEX
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 Nov 26, 2014 as substantially equivalent to K110179 (Incontrol Medical, LLC, 2012) after a 205-day review. Its family tree reaches back 8 generations to 1995. 9 later devices descend from it.
- Decided
- Nov 26, 2014
- Review
- 205 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930530 (1995). 25 ancestors in all, the oldest K813008 (1981). 9 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 7 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 6 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 5 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 4 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 3 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 2 generations backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- 1 generation backK110179 IncontrolIncontrol Medical, LLC · 2012
- This deviceK141158 APEXIncontrol Medical, LLC · 2014
- Descendant · cites it directly · 4 of its ownK142506 TensCare KegelFitTenscare, Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK191312 Perfect PFETenscare, Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK150183 ApexMIncontrol Medical, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK182022 ApexMVIncontrol Medical, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK260178 Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K142506TensCare KegelFitTenscare, Ltd. · 2015 · cites it directly4descendants
- K191312Perfect PFETenscare, Ltd. · 2019 · 2 generations on3descendants
- K150183ApexMIncontrol Medical, LLC · 2015 · cites it directly3descendants
- K182022ApexMVIncontrol Medical, LLC · 2019 · 2 generations on1descendant
- K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −7 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −6 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −5 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −4 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −3 | 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 | — |
| 0 (this device) | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| +1 | K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015 | — |
| +2 | K191312 | Perfect PFE | Tenscare, Ltd. | 2019 | — |
| +1 | K150183 | ApexM | Incontrol Medical, LLC | 2015 | — |
| +2 | K182022 | ApexMV | Incontrol Medical, LLC | 2019 | — |
| +3 | K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K110179 | IncontrolSummary page 4…Name Product Code Manufacturer InControl Medical, LLC K110179 InTone KPI 3225 Gateway Road, Ste. 250… | 2012 |
What descends from it? (9)
2 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 19 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K142506 (Tenscare, Ltd., 2015) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K110179.
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. 2014, 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?
Apex is a non-implanted muscle stimulator designed to treat female stress urinary incontinence.
It applies stimulation to the pelvic floor muscles to improve strength and support.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141158: APEX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141158
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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