510(k) · Cleared
ClearedLiberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044)
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 May 23, 1997 as substantially equivalent to K960496 (Utah Medical Products, Inc., 1996) and 1 other predicate after a 134-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- May 23, 1997
- Review
- 134 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K891773 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 1 generation backK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
- This deviceK970077 Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044)Utah Medical Products, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −1 | K960496 | Liberty Lite PFS System | Utah Medical Products, Inc. | 1996 | — |
| 0 (this device) | K970077 | Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044) | Utah Medical Products, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 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 |
|---|---|---|---|
| * | K960496 | Liberty Lite PFS SystemSummary page 1…ical Products, Inc. (UMP) Liberty Plus System (PFS-300) is substantially equivalent to a combination of the UMP Liberty PFS System (PFS-200), cleared for marketing under K960496, with the Cardio Design Pty Ltd PFX Pelvic Floor Exerciser, cleared for marketing under K945611. The device consists of a hand h… | 1996 |
| * | K945611 | PeritronSummary page 1…tion of the UMP Liberty PFS System (PFS-200), cleared for marketing under K960496, with the Cardio Design Pty Ltd PFX Pelvic Floor Exerciser, cleared for marketing under K945611. The device consists of a hand held electrostimulation unit and an injection molded thermoplastic applicator that supports two s… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 4 ancestors has a recall.
- 5 other devices also cite its predicate K960496.
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?
This device is intended as therapeutic aid in the conservative treatment of stress incontinence, urge incontinence or mixed stress and urge incontinence in women. Patients appropriate for this therapy should be selected using the following criteria: Indications: • Good general health, both mentally and physically. • Urge incontinence due to detrusor instability or of idiopathic origin. • Stress incontinence not associated with intrinsic sphincter…
Read the full statement (169 words)
This device is intended as therapeutic aid in the conservative treatment of stress incontinence, urge incontinence or mixed stress and urge incontinence in women. Patients appropriate for this therapy should be selected using the following criteria:
Indications:
• Good general health, both mentally and physically.
• Urge incontinence due to detrusor instability or of idiopathic origin.
• Stress incontinence not associated with intrinsic sphincter deficiency.
• Mixed incontinence.
• Ability of patient to understand and demonstrate understanding of the use of the Liberty Plus System.
• Willingness to comply with the therapy plan.
Contraindications:
• Use of a cardiac pacemaker, or a history of rate or conductive disturbances.
• Neurological deficiency that would not permit proper sensory perception or stimulation.
• Currently pregnant or attempting to get pregnant.
• Anatomical vaginal structure that does not permit proper and complete placement of the vaginal probe.
• Irregular menstrual bleeding cycles.
• Any urinary or vaginal infections, localized lesions or other undiagnosed symptoms.
• History of urinary retention or current symptoms.
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/K970077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970077: Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970077
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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