510(k) · Cleared
ClearedUnicare (K-UNICARE-USA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenscare, Ltd. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Oct 20, 2023 as substantially equivalent to K191312 (Tenscare, Ltd., 2019) after a 197-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Oct 20, 2023
- Review
- 197 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K930530 (1995). 40 ancestors in all, the oldest K813008 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 7 generations between
- 3 generations backK141158 APEXIncontrol Medical, LLC · 2014
- 2 generations backK142506 TensCare KegelFitTenscare, Ltd. · 2015
- 1 generation backK191312 Perfect PFETenscare, Ltd. · 2019
- This deviceK230983 Unicare (K-UNICARE-USA)Tenscare, Ltd. · 2023
Show all 11 generations
- Root · 11 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 10 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 9 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 8 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 7 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 6 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 5 generations backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- 4 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 3 generations backK141158 APEXIncontrol Medical, LLC · 2014
- 2 generations backK142506 TensCare KegelFitTenscare, Ltd. · 2015
- 1 generation backK191312 Perfect PFETenscare, Ltd. · 2019
- This deviceK230983 Unicare (K-UNICARE-USA)Tenscare, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −10 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −9 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −8 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −7 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −6 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| −5 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| −4 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| −3 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| −2 | K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015 | — |
| −1 | K191312 | Perfect PFE | Tenscare, Ltd. | 2019 | — |
| 0 (this device) | K230983 | Unicare (K-UNICARE-USA) | Tenscare, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 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 |
|---|---|---|---|
| * | K191312 | Perfect PFESummary page 4…II Panel: Gastroenterology/Urology Product Code: KPI 3. Predicate Devices 510(k) Number: K191312 Trade Name of the Device: Perfect PFE The predicate device has not been subject to a design related recall.… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 40 ancestors has a recall.
- 2 other devices also cite its predicate K191312.
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. 2023, 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?
Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230983: Unicare (K-UNICARE-USA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230983
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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