510(k) · Cleared
ClearedElpha 2000 Conti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dan Med, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Aug 14, 1997 after a 274-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 40 later devices descend from it.
- Decided
- Aug 14, 1997
- Review
- 274 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 2 citing it directly.
- This deviceK964738 Elpha 2000 ContiDan Med, Inc. · 1997
- Descendant · cites it directly · 38 of its ownK013612 Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002
- Descendant · 2 generations on · 37 of its ownK050483 Evadri Bladder Control SystemsHollister, Inc. · 2005
- Descendant · 3 generations on · 36 of its ownK053434 Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006
- Descendant · 4 generations on · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · 3 generations on · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K013612Incare Pelvic Floor Therapy SystemHollister, Inc. · 2002 · cites it directly38descendants
- K050483Evadri Bladder Control SystemsHollister, Inc. · 2005 · 2 generations on37descendants
- K053434Myotrac Infiniti Electrical StimulatorThought Technology, Ltd. · 2006 · 3 generations on36descendants
- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · 4 generations on34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964738 | Elpha 2000 Conti | Dan Med, Inc. | 1997 | — |
| +1 | K013612 | Incare Pelvic Floor Therapy System | Hollister, Inc. | 2002 | — |
| +2 | K050483 | Evadri Bladder Control Systems | Hollister, Inc. | 2005 | — |
| +3 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (40)
See all 402 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, K013612 (Hollister, Inc., 2002) has gone furthest, with 38 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 | — |
What is it indicated for?
Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system.
Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964738 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964738: Elpha 2000 Conti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964738
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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