510(k) · Cleared
ClearedVaginal 2 Electrode Stimulation/Emg Probe - Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Jun 25, 1997 as substantially equivalent to K891773 (Hollister, Inc., 1989) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1989. 6 later devices descend from it.
- Decided
- Jun 25, 1997
- Review
- 58 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K891773 (1989). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 1 generation backK970602 Vaginal 2 Electrode Stimulation/Emg Probe-SmallHollister, Inc. · 1997
- This deviceK971541 Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK122194 Life-Care Vaginal Probe Life-Care Anal ProbeEveryway Medical Instruments Co.,Ltd · 2013
- Descendant · 2 generations on · 1 of its ownK222528 Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA)…Well-Life Healthcare Limited · 2022
- Descendant · cites it directly · 1 of its ownK161055 Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/…Fuji Dynamics, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK231166 Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic…Zmi Electronics, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK210441 Incontinence ProbeShenzhen Med-Link Electronics Tech Co., Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122194Life-Care Vaginal Probe Life-Care Anal ProbeEveryway Medical Instruments Co.,Ltd · 2013 · cites it directly3descendants
- K222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence…Well-Life Healthcare Limited · 2022 · 2 generations on1descendant
- K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/…Fuji Dynamics, Ltd. · 2016 · cites it directly1descendant
- K231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe…Zmi Electronics, Ltd. · 2024 · 3 generations on0descendants
- K210441Incontinence ProbeShenzhen Med-Link Electronics Tech Co., Ltd. · 2021 · 2 generations on0descendants
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 | K970602 | Vaginal 2 Electrode Stimulation/Emg Probe-Small | Hollister, Inc. | 1997 | — |
| 0 (this device) | K971541 | Vaginal 2 Electrode Stimulation/Emg Probe - Tampon | Hollister, Inc. | 1997 | — |
| +1 | K122194 | Life-Care Vaginal Probe Life-Care Anal Probe | Everyway Medical Instruments Co.,Ltd | 2013 | — |
| +2 | K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life… | Well-Life Healthcare Limited | 2022 | — |
| +1 | K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/… | Fuji Dynamics, Ltd. | 2016 | — |
| +3 | K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor… | Zmi Electronics, Ltd. | 2024 | — |
| +2 | K210441 | Incontinence Probe | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K891773 | Microgyn II Elec Stim Device Treat of Urin IncontiSummary page 1…918-3860 Date Summary Prepared - April 24, 1997 2. Name of Device: Vaginal Stimulation/EMG Probe - Tampon 3. Name of Predicate Device(s) Vaginal Stimulation/EMG Probe, K891773 and K930530 Vaginal Stimulation/EMG Probe - Small K970602 ) 4. Description of Device Hollister Incorporated through it’s InCare… | 1989 |
| * | K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncSummary page 1…e Summary Prepared - April 24, 1997 2. Name of Device: Vaginal Stimulation/EMG Probe - Tampon 3. Name of Predicate Device(s) Vaginal Stimulation/EMG Probe, K891773 and K930530 Vaginal Stimulation/EMG Probe - Small K970602 ) 4. Description of Device Hollister Incorporated through it’s InCare Division cur… | 1995 |
| * | K970602 | Vaginal 2 Electrode Stimulation/Emg Probe-SmallSummary page 1…f Device: Vaginal Stimulation/EMG Probe - Tampon 3. Name of Predicate Device(s) Vaginal Stimulation/EMG Probe, K891773 and K930530 Vaginal Stimulation/EMG Probe - Small K970602 ) 4. Description of Device Hollister Incorporated through it’s InCare Division currently markets a vaginal 2-electrode Stimulati… | 1997 |
What descends from it? (6)
2 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 1 company; a new generation was cleared every 7.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K122194 (Everyway Medical Instruments Co.,Ltd, 2013) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K891773.
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 Vaginal Stimulation/EMG Probe - Tampon, is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
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/K971541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971541: Vaginal 2 Electrode Stimulation/Emg Probe - Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971541
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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