510(k) · Cleared
ClearedInnova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode (199205)
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 Jan 24, 1997 as substantially equivalent to K910081 (Empi, 1991) and 3 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1989. 6 later devices descend from it.
- Decided
- Jan 24, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K891773 (1989). 5 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 1 generation backK954272 Innova Rectal Stimulaton ElectrodeEmpi · 1996
- This deviceK964577 Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse…Empi · 1997
- Descendant · cites it directly · 3 of its ownK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK020952 Surx RF SystemSurx, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK042132 Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK983206 Small Vaginal/Rectal ElectrodeEmpi · 1998
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc. · 2002 · cites it directly3descendants
- K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002 · 2 generations on2descendants
- K020952Surx RF SystemSurx, Inc. · 2002 · 2 generations on1descendant
- K042132Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · 3 generations on0descendants
- K983206Small Vaginal/Rectal ElectrodeEmpi · 1998 · cites it directly0descendants
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 | K954272 | Innova Rectal Stimulaton Electrode | Empi | 1996 | — |
| 0 (this device) | K964577 | Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small… | Empi | 1997 | — |
| +1 | K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP… | Surx, Inc. | 2002 | — |
| +2 | K020126 | Modification to Surx Radiofrequency Electrosurgical Generator System and… | Surx, Inc. | 2002 | — |
| +2 | K020952 | Surx RF System | Surx, Inc. | 2002 | — |
| +3 | K042132 | Novasys Transurethral RF System | Novasys Medical, Inc. | 2004 | 1 |
| +1 | K983206 | Small Vaginal/Rectal Electrode | Empi | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K910081 | TBDSummary page 1…nova® ComfortPulse® Vaginal Electrode and Innova® ComfortPulse® Small Vaginal Electrode B. Name of Predicate Devices ¢ Empi, Inc. Innova® Vaginal Stimulation Electrode K910081 ¢ Empi, Inc. Innova® Vaginal EMG Sensing Electrode K940091 ¢ Empi, Inc. Innova® Rectal or Small Vaginal EMG Sensing Electrode K9… | 1991 |
| * | K940091 | Innova Vaginal Emg Sensing ElectrodeSummary page 1…lse® Small Vaginal Electrode B. Name of Predicate Devices ¢ Empi, Inc. Innova® Vaginal Stimulation Electrode K910081 ¢ Empi, Inc. Innova® Vaginal EMG Sensing Electrode K940091 ¢ Empi, Inc. Innova® Rectal or Small Vaginal EMG Sensing Electrode K952688 ¢ Empi, Inc. Innova® Rectal Stimulation Electrode K95… | 1994 |
| * | K952688 | Innova Rectal or Small Vaginal Emg Sensing ElectrodeSummary page 1…ova® Vaginal Stimulation Electrode K910081 ¢ Empi, Inc. Innova® Vaginal EMG Sensing Electrode K940091 ¢ Empi, Inc. Innova® Rectal or Small Vaginal EMG Sensing Electrode K952688 ¢ Empi, Inc. Innova® Rectal Stimulation Electrode K954272 C. Device Deseripti The Innova® ComfortPulse® Vaginal Electrodes, sma… | 1995 |
| * | K954272 | Innova Rectal Stimulaton ElectrodeSummary page 1…nova® Vaginal EMG Sensing Electrode K940091 ¢ Empi, Inc. Innova® Rectal or Small Vaginal EMG Sensing Electrode K952688 ¢ Empi, Inc. Innova® Rectal Stimulation Electrode K954272 C. Device Deseripti The Innova® ComfortPulse® Vaginal Electrodes, small and standard sizes, have three conductive elements sepa… | 1996 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K011190 (Surx, Inc., 2002) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K910081.
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 Innova® ComfortPulse® Vaginal Electrodes are a component of the Innova Pelvic Floor Stimulation (PFS) System which is indicated for use in the treatment of urinary incontinence. These electrodes are also a component of the Innova® Clinical EMG System which is indicated for monitoring and evaluating EMG activity of the pelvic floor 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/K964577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964577: Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode (199205).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964577
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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