510(k) · Cleared
ClearedIncare Pelvic Floor Therapy System with Desktop Computer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Dec 23, 1997 as substantially equivalent to K961872 (Hollister, Inc., 1996) after a 60-day review. Its family tree reaches back 2 generations to 1995. 42 later devices descend from it.
- Decided
- Dec 23, 1997
- Review
- 60 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930530 (1995). 42 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK930530 Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncHollister, Inc. · 1995
- 1 generation backK961872 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1996
- This deviceK974048 Incare Pelvic Floor Therapy System with Desktop ComputerHollister, Inc. · 1997
- Descendant · cites it directly · 39 of its ownK023906 Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 2003
- Descendant · cites it directly · 38 of its ownK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- 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
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K023906Pathway CTS2000 Pelvic Floor Training SystemThe Prometheus Group · 2003 · cites it directly39descendants
- K013612Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002 · cites it directly38descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc | Hollister, Inc. | 1995 | — |
| −1 | K961872 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1996 | — |
| 0 (this device) | K974048 | Incare Pelvic Floor Therapy System with Desktop Computer | Hollister, Inc. | 1997 | — |
| +1 | K023906 | Pathway CTS2000 Pelvic Floor Training System | The Prometheus Group | 2003 | — |
| +1 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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? (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 |
|---|---|---|---|
| * | K961872 | Incare Pelvic Floor Therapy System with Desktop ComputerSummary page 1…ober 21, 1997 2. Name of Device: InCare Pelvic Floor Therapy System with Desktop Computer 3. Name of Predicate Device(s) Hollister PRS9300 Pelvic Floor Therapy System, K961872 4. Description of Device ‘ The InCare Pelvic Floor Therapy System with Desktop Computer is an office based instrument that is in… | 1996 |
What descends from it? (42)
See all 425 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023906 | Pathway CTS2000 Pelvic Floor Training System | 2003 | 39 |
| K013612 | Incare Pelvic Floor Therapy System | 2002 | 38 |
| K050483 | Evadri Bladder Control Systems | 2005 | 37 |
| K053434 | Myotrac Infiniti Electrical Stimulator | 2006 | 36 |
| K993411 | Femiscan Clinic System, Model FS-Ictra and Femiscan Personal System, Model FS-HMTR | 2000 | 0 |
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 2 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K023906 (The Prometheus Group, 2003) has gone furthest, with 39 descendants of its own.
- 4 other devices also cite its predicate K961872.
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?
The biofeedback components of the InCare Pelvic Floor Therapy System with Desktop Computer are intended to provide electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
The electrical stimulation component of the InCare Pelvic Floor Therapy System with Desktop Computer provides stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974048: Incare Pelvic Floor Therapy System with Desktop Computer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974048
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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