510(k) · Cleared
ClearedInnosense Pelvic Floor Stimulation and Electromyography System
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 Jun 30, 1997 as substantially equivalent to K892649 (Verimed Holdings, Inc., 1989) and 4 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Jun 30, 1997
- Review
- 63 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K891773 (1989). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 2 generations backK960496 Liberty Lite PFS SystemUtah Medical Products, Inc. · 1996
- 1 generation backK970307 Minnova Pelvic Floor Stimulation SystemEmpi · 1997
- This deviceK971527 Innosense Pelvic Floor Stimulation and Electromyography SystemEmpi · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891773 | Microgyn II Elec Stim Device Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −2 | K960496 | Liberty Lite PFS System | Utah Medical Products, Inc. | 1996 | — |
| −1 | K970307 | Minnova Pelvic Floor Stimulation System | Empi | 1997 | — |
| 0 (this device) | K971527 | Innosense Pelvic Floor Stimulation and Electromyography System | Empi | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K892649 | Verimed Myoexorciser Iii (Myo Iii)Summary page 1…ation and Biofeedback Device Classification Name: Non-Implanted Electrical Continence Device Biofeedback Device B. Name of Predicate Devices ¢ Verimed Myoexerciser I1I, K892649 ¢ Thought Technology InControl, K935213 ¢ Verimed Veristim, K893220 + Innova Pelvic Floor Stimulation System, K941911 ¢ Minnova P… | 1989 |
| * | K935213 | IncontrolSummary page 1…ion Name: Non-Implanted Electrical Continence Device Biofeedback Device B. Name of Predicate Devices ¢ Verimed Myoexerciser I1I, K892649 ¢ Thought Technology InControl, K935213 ¢ Verimed Veristim, K893220 + Innova Pelvic Floor Stimulation System, K941911 ¢ Minnova Pelvic Floor Stimulation System, K970307… | 1995 |
| * | K893220 | Verimed Myoexorciser VeristimSummary page 1…trical Continence Device Biofeedback Device B. Name of Predicate Devices ¢ Verimed Myoexerciser I1I, K892649 ¢ Thought Technology InControl, K935213 ¢ Verimed Veristim, K893220 + Innova Pelvic Floor Stimulation System, K941911 ¢ Minnova Pelvic Floor Stimulation System, K970307 C. Device Description List… | 1990 |
| * | K941911 | Innova Pelvic Floor Stimulation SystemSummary page 1…me of Predicate Devices ¢ Verimed Myoexerciser I1I, K892649 ¢ Thought Technology InControl, K935213 ¢ Verimed Veristim, K893220 + Innova Pelvic Floor Stimulation System, K941911 ¢ Minnova Pelvic Floor Stimulation System, K970307 C. Device Description List of Components The InnoSense Pelvic Floor Stimulati… | 1995 |
| * | K970307 | Minnova Pelvic Floor Stimulation SystemSummary page 1…K892649 ¢ Thought Technology InControl, K935213 ¢ Verimed Veristim, K893220 + Innova Pelvic Floor Stimulation System, K941911 ¢ Minnova Pelvic Floor Stimulation System, K970307 C. Device Description List of Components The InnoSense Pelvic Floor Stimulation and Electromyography (EMG) System is comprised o… | 1997 |
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 3 companies; a new generation was cleared every 10 months on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K892649.
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 InnoSense System is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflexive mechanisms. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.
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/K971527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971527: Innosense Pelvic Floor Stimulation and Electromyography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971527
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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