510(k) · Cleared
ClearedInnova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable Electrode
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 Aug 14, 1997 as substantially equivalent to K970307 (Empi, 1997) and 3 other predicates after a 73-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Aug 14, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K891773 (1989). 10 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 backK954272 Innova Rectal Stimulaton ElectrodeEmpi · 1996
- 1 generation backK964577 Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse…Empi · 1997
- This deviceK972054 Innova Rectal Reusable Electrode/Comfortpulse Regular or Small…Empi · 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 | K954272 | Innova Rectal Stimulaton Electrode | Empi | 1996 | — |
| −1 | K964577 | Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small… | Empi | 1997 | — |
| 0 (this device) | K972054 | Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable… | Empi | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 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? (4)
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 |
|---|---|---|---|
| * | K970307 | Minnova Pelvic Floor Stimulation SystemSummary page 1…s (Small and Standard) Innova® Rectal Electrode mmon Name: Pelvic Floor Stimulation Device Name of Predicate Devices e Empi, Inc. Minnova Pelvic Floor Stimulation System K970307 e Empi, Inc. ComfortPulse Regular and Small Electrode K964577 e Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode K… | 1997 |
| * | K964577 | Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal…Summary page 1…vic Floor Stimulation Device Name of Predicate Devices e Empi, Inc. Minnova Pelvic Floor Stimulation System K970307 e Empi, Inc. ComfortPulse Regular and Small Electrode K964577 e Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode K952688 e Empi, Inc. Innova Rectal Stimulation Electrode K95427… | 1997 |
| * | K952688 | Innova Rectal or Small Vaginal Emg Sensing ElectrodeSummary page 1…a Pelvic Floor Stimulation System K970307 e Empi, Inc. ComfortPulse Regular and Small Electrode K964577 e Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode K952688 e Empi, Inc. Innova Rectal Stimulation Electrode K954272 Device Description The Reusable Vaginal and Rectal Electrodes are ident… | 1995 |
| * | K954272 | Innova Rectal Stimulaton ElectrodeSummary page 1…mfortPulse Regular and Small Electrode K964577 e Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode K952688 e Empi, Inc. Innova Rectal Stimulation Electrode K954272 Device Description The Reusable Vaginal and Rectal Electrodes are identical to the predicate devices except for the addition of… | 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 9 months on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K970307.
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 electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed.
The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable if reuse instructions are followed.
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/K972054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972054: Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972054
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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