510(k) · Cleared
ClearedPerfect PFE
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 Nov 1, 2019 as substantially equivalent to K142506 (Tenscare, Ltd., 2015) and 1 other predicate after a 170-day review. Its family tree reaches back 10 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 1, 2019
- Review
- 170 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K930530 (1995). 39 ancestors in all, the oldest K813008 (1981). 3 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 6 generations between
- 3 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 2 generations backK141158 APEXIncontrol Medical, LLC · 2014
- 1 generation backK142506 TensCare KegelFitTenscare, Ltd. · 2015
- This deviceK191312 Perfect PFETenscare, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK260178 Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251760 Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK230983 Unicare (K-UNICARE-USA)Tenscare, Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 9 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 8 generations backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- 7 generations backK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 6 generations backK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- 5 generations backK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- 4 generations backK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- 3 generations backK110179 IncontrolIncontrol Medical, LLC · 2012
- 2 generations backK141158 APEXIncontrol Medical, LLC · 2014
- 1 generation backK142506 TensCare KegelFitTenscare, Ltd. · 2015
- This deviceK191312 Perfect PFETenscare, Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd. · 2026 · cites it directly0descendants
- K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd. · 2026 · cites it directly0descendants
- K230983Unicare (K-UNICARE-USA)Tenscare, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −9 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −8 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| −7 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| −6 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| −5 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| −4 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| −3 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| −2 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| −1 | K142506 | TensCare KegelFit | Tenscare, Ltd. | 2015 | — |
| 0 (this device) | K191312 | Perfect PFE | Tenscare, Ltd. | 2019 | — |
| +1 | K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026 | — |
| +1 | K251760 | Well-Life Incontinence Stimulation System (WL-2405i (P)) | Well-Life Healthcare, Ltd. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K142506 | TensCare KegelFitSummary page 4…III Predicate Device: Predicate Device (1): Primary Predicate Trade/Device Name: Tenscare KegelFit Manufacturer: TensCare Ltd 510(k) Number: K142506 Product Code: KPI Type of Use: Over-The-Counter Use (OTC Use) Regulatory Class: Class II === Page 5… | 2015 |
| * | K141643 | YarlapSummary page 5…Page 2 of 7 Predicate Device (2): Secondary Predicate Trade/Device Name: Yarlap Manufacturer: International Trade Group, Inc. 510(k) Number: K141643 Product Code: KPI Type of Use: Prescription Use and Over-The-Counter Use (OTC Use) Regulatory Class: C… | 2015 |
What descends from it? (3)
3 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 24 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 39 ancestors has a recall.
- Of its descendants, K260178 (Shenzhen Konmed Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
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. 2019, 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?
Perfect PFE 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/K191312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191312: Perfect PFE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191312
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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