510(k) · Cleared
ClearedElpha 4 Conti
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Danmeter A/S · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Dec 3, 2003 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 35 later devices descend from it.
- Decided
- Dec 3, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 1 citing it directly.
- This deviceK032988 Elpha 4 ContiDanmeter A/S · 2003
- Descendant · cites it directly · 34 of its ownK080950 Stiwell MED4Otto Bock, Austria GmbH · 2009
- Descendant · 2 generations on · 21 of its ownK110179 IncontrolIncontrol Medical, LLC · 2012
- Descendant · 3 generations on · 10 of its ownK134020 IntonemvIncontrol Medical, LLC · 2014
- Descendant · 3 generations on · 9 of its ownK141158 APEXIncontrol Medical, LLC · 2014
- Descendant · 4 generations on · 6 of its ownK181497 HPM-6000UFBTL Industries, Inc. · 2018
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K080950Stiwell MED4Otto Bock, Austria GmbH · 2009 · cites it directly34descendants
- K110179IncontrolIncontrol Medical, LLC · 2012 · 2 generations on21descendants
- K134020IntonemvIncontrol Medical, LLC · 2014 · 3 generations on10descendants
- K141158APEXIncontrol Medical, LLC · 2014 · 3 generations on9descendants
- K181497HPM-6000UFBTL Industries, Inc. · 2018 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032988 | Elpha 4 Conti | Danmeter A/S | 2003 | — |
| +1 | K080950 | Stiwell MED4 | Otto Bock, Austria GmbH | 2009 | — |
| +2 | K110179 | Incontrol | Incontrol Medical, LLC | 2012 | — |
| +3 | K134020 | Intonemv | Incontrol Medical, LLC | 2014 | — |
| +3 | K141158 | APEX | Incontrol Medical, LLC | 2014 | — |
| +4 | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 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? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080950 | Stiwell MED4 | 2009 | 34 |
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, K080950 (Otto Bock, Austria GmbH, 2009) has gone furthest, with 34 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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032988: Elpha 4 Conti.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032988
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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