510(k) · Cleared
ClearedPelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Changkun Technology Co., Ltd. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on May 6, 2026 as substantially equivalent to K141643 (International Trade Group, Inc., 2015) after a 266-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- May 6, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K891773 (1989). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 5 generations backK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
- 4 generations backK023905 Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003
- 3 generations backK033256 Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003
- 2 generations backK081480 KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008
- 1 generation backK141643 YarlapInternational Trade Group, Inc. · 2015
- This deviceK252552 Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −5 | K960496 | Liberty Lite PFS System | Utah Medical Products, Inc. | 1996 | — |
| −4 | K023905 | Athena Pelvic Muscle Trainer | Athena Feminine Technologies, Inc. | 2003 | — |
| −3 | K033256 | Athena Pelvic Muscle Trainer II | Athena Feminine Technologies, Inc. | 2003 | — |
| −2 | K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400 | Ne Services, Ltd. | 2008 | — |
| −1 | K141643 | Yarlap | International Trade Group, Inc. | 2015 | — |
| 0 (this device) | K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | Shenzhen Changkun Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K141643 | YarlapSummary page 5…ICES Predicate device: Manufacturer Predicate Device 510(k) Number Approval Date International Trade Yarlap K141643 April 24, 2015 Group, Inc. Reference device I: Manufacturer Predicate Device 510(k) Nu… | 2015 |
| † | K163288 | Pelvifine Pelvic Muscle Trainer | 2018 |
| † | K200293 | InMode System with vTone Applicator | 2020 |
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 37 years and passes through 6 companies; a new generation was cleared every 6.8 years on median.
- None of the 12 ancestors has a recall.
- 4 other devices also cite its predicate K141643.
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. 2026, 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?
Pelvic Floor Rehabilitation Therapy Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress and urge urinary incontinence in women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252552: Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252552
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026