510(k) · Cleared
ClearedLiberty Rectal Pelvic Floor Exerciser
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 10, 1997 as substantially equivalent to K960496 (Utah Medical Products, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Feb 10, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K891773 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
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) | K964526 | Liberty Rectal Pelvic Floor Exerciser | Utah Medical Products, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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…Medical Products, Inc. (UMP) Liberty Rectal Pelvic Floor Exerciser (PFS-043) is substantially equivalent to the UMP Liberty Probe (PFS-041), cleared for marketing under K960496, and to the Hollister InCare Anal Applicator (ICAA), cleared for marketing under K891773. The device consists of an injection mo… | 1996 |
| * | K891773 | Microgyn II Elec Stim Device Treat of Urin IncontiSummary page 1…ially equivalent to the UMP Liberty Probe (PFS-041), cleared for marketing under K960496, and to the Hollister InCare Anal Applicator (ICAA), cleared for marketing under K891773. The device consists of an injection molded thermoplastic applicator that supports two stainless steel electrode rings that appl… | 1989 |
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 3 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?
The PFS-043 is indicated for use to help train the pelvic floor muscles using electrical stimulation. The PFS-043 is a rectal applicator that is used with the UMP Liberty PFS System (PFS), which is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the applicator.
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/K964526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964526: Liberty Rectal Pelvic Floor Exerciser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964526
Report an extraction error
Are you the manufacturer?
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