510(k) · Cleared
ClearedTBD
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 Jul 15, 1991 after a 187-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it.
- Decided
- Jul 15, 1991
- Review
- 187 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 3 citing it directly.
- This deviceK910081 TBDEmpi · 1991
- Descendant · cites it directly · 26 of its ownK963222 Microgyn Plus Stimulation DeviceHollister, Inc. · 1996
- Descendant · 2 generations on · 14 of its ownK023905 Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003
- Descendant · 3 generations on · 13 of its ownK033256 Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003
- Descendant · 4 generations on · 12 of its ownK081480 KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008
- Descendant · 5 generations on · 10 of its ownK141643 YarlapInternational Trade Group, Inc. · 2015
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K963222Microgyn Plus Stimulation DeviceHollister, Inc. · 1996 · cites it directly26descendants
- K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003 · 2 generations on14descendants
- K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003 · 3 generations on13descendants
- K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008 · 4 generations on12descendants
- K141643YarlapInternational Trade Group, Inc. · 2015 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910081 | TBD | Empi | 1991 | — |
| +1 | K963222 | Microgyn Plus Stimulation Device | Hollister, Inc. | 1996 | — |
| +2 | K023905 | Athena Pelvic Muscle Trainer | Athena Feminine Technologies, Inc. | 2003 | — |
| +3 | K033256 | Athena Pelvic Muscle Trainer II | Athena Feminine Technologies, Inc. | 2003 | — |
| +4 | K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400 | Ne Services, Ltd. | 2008 | — |
| +5 | K141643 | Yarlap | International Trade Group, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (35)
See all 353 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, K963222 (Hollister, Inc., 1996) has gone furthest, with 26 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/K910081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910081: TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910081
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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