510(k) · Cleared
ClearedLiberty Lite PFS System
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 Jun 27, 1996 as substantially equivalent to K943250 (Utah Medical Products, Inc., 1995) and 1 other predicate after a 147-day review. Its family tree reaches back 1 generation to 1989. 30 later devices descend from it.
- Decided
- Jun 27, 1996
- Review
- 147 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891773 (1989). 2 ancestors in all. 30 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- This deviceK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
- Descendant · cites it directly · 14 of its ownK023905 Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK033256 Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003
- Descendant · 2 generations on · 12 of its ownK081480 KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008
- Descendant · cites it directly · 12 of its ownK970307 Minnova Pelvic Floor Stimulation SystemEmpi · 1997
- Descendant · 3 generations on · 10 of its ownK141643 YarlapInternational Trade Group, Inc. · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K023905Athena Pelvic Muscle TrainerAthena Feminine Technologies, Inc. · 2003 · cites it directly14descendants
- K033256Athena Pelvic Muscle Trainer IIAthena Feminine Technologies, Inc. · 2003 · cites it directly13descendants
- K081480KEGEL8 Pelvic Exerciser, Model Oph 400Ne Services, Ltd. · 2008 · 2 generations on12descendants
- K970307Minnova Pelvic Floor Stimulation SystemEmpi · 1997 · cites it directly12descendants
- K141643YarlapInternational Trade Group, Inc. · 2015 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| 0 (this device) | K960496 | Liberty Lite PFS System | Utah Medical Products, Inc. | 1996 | — |
| +1 | K023905 | Athena Pelvic Muscle Trainer | Athena Feminine Technologies, Inc. | 2003 | — |
| +1 | K033256 | Athena Pelvic Muscle Trainer II | Athena Feminine Technologies, Inc. | 2003 | — |
| +2 | K081480 | KEGEL8 Pelvic Exerciser, Model Oph 400 | Ne Services, Ltd. | 2008 | — |
| +1 | K970307 | Minnova Pelvic Floor Stimulation System | Empi | 1997 | — |
| +3 | K141643 | Yarlap | International Trade Group, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943250 | LibertySummary page 1…need for active involvement of the patient or the physician. ‘( Liberty Lite is substantially equivalent to the UMP Liberty System cleared for marketing under N 510(k) K943250 and the Hollister InCare Applicator cleared for marketing under 510(k) K891773. Although the Liberty Lite Stimulator utilizes a s… | 1995 |
| * | K891773 | Microgyn II Elec Stim Device Treat of Urin IncontiSummary page 1…s substantially equivalent to the UMP Liberty System cleared for marketing under N 510(k) K943250 and the Hollister InCare Applicator cleared for marketing under 510(k) K891773. Although the Liberty Lite Stimulator utilizes a simplified user interface, the stimulation output has equivalent wavcforms. The… | 1989 |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023905 | Athena Pelvic Muscle Trainer | 2003 | 14 |
| K033256 | Athena Pelvic Muscle Trainer II | 2003 | 13 |
| K970307 | Minnova Pelvic Floor Stimulation System | 1997 | 12 |
| K973096 | Neotonus Model 1000 Muscle Stimulator System | 1998 | 9 |
| K970077 | Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044) | 1997 | 0 |
| K964526 | Liberty Rectal Pelvic Floor Exerciser | 1997 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K023905 (Athena Feminine Technologies, Inc., 2003) has gone furthest, with 14 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?
The UMP Liberty Lite PFS System is a battery operated electrostimulation device with an intravaginal applicator that applies electrical stimulation through electrodes on the applicator, to help train neuromuscular tissue in the pelvic floor in order to improve or restore urinary continence in females.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960496: Liberty Lite PFS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960496
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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