510(k) · Cleared
ClearedInnova Pelvic Floor Stimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Jan 20, 1995 after a 276-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Jan 20, 1995
- Review
- 276 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK941911 Innova Pelvic Floor Stimulation SystemEmpi · 1995
- Descendant · cites it directly · 12 of its ownK970307 Minnova Pelvic Floor Stimulation SystemEmpi · 1997
- Descendant · 2 generations on · 9 of its ownK973096 Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc. · 1998
- Descendant · 3 generations on · 7 of its ownK162010 HPM-6000UBTL Industries, Inc. · 2016
- Descendant · 4 generations on · 6 of its ownK181497 HPM-6000UFBTL Industries, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK103698 Tenscare Itouch Sure Model ItsTenscare, Ltd. · 2011
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K970307Minnova Pelvic Floor Stimulation SystemEmpi · 1997 · cites it directly12descendants
- K973096Neotonus Model 1000 Muscle Stimulator SystemNeotonus, Inc. · 1998 · 2 generations on9descendants
- K162010HPM-6000UBTL Industries, Inc. · 2016 · 3 generations on7descendants
- K181497HPM-6000UFBTL Industries, Inc. · 2018 · 4 generations on6descendants
- K103698Tenscare Itouch Sure Model ItsTenscare, Ltd. · 2011 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941911 | Innova Pelvic Floor Stimulation System | Empi | 1995 | — |
| +1 | K970307 | Minnova Pelvic Floor Stimulation System | Empi | 1997 | — |
| +2 | K973096 | Neotonus Model 1000 Muscle Stimulator System | Neotonus, Inc. | 1998 | — |
| +3 | K162010 | HPM-6000U | BTL Industries, Inc. | 2016 | — |
| +4 | K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 | — |
| +1 | K103698 | Tenscare Itouch Sure Model Its | Tenscare, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (20)
See all 203 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, K970307 (Empi, 1997) has gone furthest, with 12 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/K941911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941911: Innova Pelvic Floor Stimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941911
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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