510(k) · Cleared
ClearedPathway CTS2000 Pelvic Floor Training System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Prometheus Group · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Feb 19, 2003 as substantially equivalent to K001515 (The Prometheus Group, 2000) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1995. 39 later devices descend from it.
- Decided
- Feb 19, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930530 (1995). 4 ancestors in all. 39 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 2 generations backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- 1 generation backK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- This deviceK023906 Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 2003
- Descendant · cites it directly · 37 of its ownK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- Descendant · cites it directly · 36 of its ownK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- Descendant · 2 generations on · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · 2 generations on · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · 2 generations on · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K050483Evadri Bladder Control SystemsHollister, Inc. · 2005 · cites it directly37descendants
- K053434Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006 · cites it directly36descendants
- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · 2 generations on34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · 2 generations on21descendants
- K134020IntonemvIncontrol Medical, LLC · 2014 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −2 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| −1 | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| 0 (this device) | K023906 | Pathway CTS2000 Pelvic Floor Training System | The Prometheus Group | 2003 | — |
| +1 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| +1 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| +2 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +2 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| +2 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 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? (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 |
|---|---|---|---|
| * | K001515 | Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000 | 2000 |
| * | K974048 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 2…lvic Floor Training System KO01 5 15 Manufacturer : The Prometheus Group Trade Name: Hollister InCare PRS Pelvic Floor Therapy System K974048 Manufacturer: Hollister, Inc. Description of Device: The Pathway CTS2000 Pelvic Floor Train… | 1997 |
| † | K993976 | Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer Sensor | 2000 |
| † | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | 1989 |
| † | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | 1995 |
| † | K934552 | Peripump | 1995 |
| † | K891774 | Contimed II Biofeedback Dev Treat of Urin Inconti | 1989 |
What descends from it? (39)
See all 393 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 8 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050483 (Hollister, Inc., 2005) has gone furthest, with 37 descendants of its own.
- 3 other devices also cite its predicate K001515.
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.
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?
Urinary Incontinence: Stress, Urge and Mixed Incontinence
Neuromuscular Reeducation
Fecal Incontinence: EMG USE ONLY
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023906: Pathway CTS2000 Pelvic Floor Training System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023906
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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