510(k) · Cleared
ClearedLiberty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Utah Medical Products, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Feb 9, 1995 after a 218-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Feb 9, 1995
- Review
- 218 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly.
- This deviceK943250 LibertyUtah Medical Products, Inc. · 1995
- Descendant · cites it directly · 30 of its ownK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
- Descendant · 2 generations on · 14 of its ownK023905 Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003
- Descendant · 2 generations on · 13 of its ownK033256 Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003
- Descendant · 3 generations on · 12 of its ownK081480 KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008
- Descendant · 2 generations on · 12 of its ownK970307 Minnova Pelvic Floor Stimulation SystemEmpi · 1997
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K960496Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996 · cites it directly30descendants
- K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003 · 2 generations on14descendants
- K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003 · 2 generations on13descendants
- K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008 · 3 generations on12descendants
- K970307Minnova Pelvic Floor Stimulation SystemEmpi · 1997 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943250 | Liberty | Utah Medical Products, Inc. | 1995 | — |
| +1 | K960496 | Liberty Lite PFS System | Utah Medical Products, Inc. | 1996 | — |
| +2 | K023905 | Athena Pelvic Muscle Trainer | Athena Feminine Technologies, Inc. | 2003 | — |
| +2 | K033256 | Athena Pelvic Muscle Trainer II | Athena Feminine Technologies, Inc. | 2003 | — |
| +3 | K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400 | Ne Services, Ltd. | 2008 | — |
| +2 | K970307 | Minnova Pelvic Floor Stimulation System | Empi | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 2003 | 2 | 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? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960496 | Liberty Lite PFS System | 1996 | 30 |
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, K960496 (Utah Medical Products, Inc., 1996) has gone furthest, with 30 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/K943250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K943250: Liberty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943250
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026