510(k) · Cleared
ClearedPathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000
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 Jul 31, 2000 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 50 later devices descend from it.
- Decided
- Jul 31, 2000
- Review
- 76 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 0
50 later devices descend from it, 4 citing it directly.
- This deviceK001515 Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000The Prometheus Group · 2000
- Descendant · cites it directly · 39 of its ownK023906 Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 2003
- Descendant · cites it directly · 37 of its ownK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- Descendant · 2 generations on · 36 of its ownK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- Descendant · 3 generations on · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · 2 generations on · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K023906Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 2003 · cites it directly39descendants
- K050483Evadri Bladder Control SystemsHollister, Inc. · 2005 · cites it directly37descendants
- K053434Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006 · 2 generations on36descendants
- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · 3 generations on34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001515 | Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000 | The Prometheus Group | 2000 | — |
| +1 | K023906 | Pathway CTS2000 Pelvic Floor Training System | The Prometheus Group | 2003 | — |
| +1 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| +2 | K053434 | Myotrac Infiniti Electrical Stimulator | Thought Technology, Ltd. | 2006 | — |
| +3 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +2 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (50)
See all 504 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?
- Of its descendants, K023906 (The Prometheus Group, 2003) has gone furthest, with 39 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.
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 | — |
https://510kreport.com/device/K001515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001515: Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001515
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026