510(k) · Cleared
ClearedFuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fuji Dynamics, Ltd. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Cleared on Jul 12, 2016 as substantially equivalent to K971541 (Hollister, Inc., 1997) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Jul 12, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- KPI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K891773 (1989). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
- 2 generations backK970602 Vaginal 2 Electrode Stimulation/Emg Probe-SmallHollister, Inc. · 1997
- 1 generation backK971541 Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc. · 1997
- This deviceK161055 Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/…Fuji Dynamics, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK210441 Incontinence ProbeShenzhen Med-Link Electronics Tech Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210441Incontinence ProbeShenzhen Med-Link Electronics Tech Co., Ltd. · 2021 · cites it directly0descendants
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 | K970602 | Vaginal 2 Electrode Stimulation/Emg Probe-Small | Hollister, Inc. | 1997 | — |
| −1 | K971541 | Vaginal 2 Electrode Stimulation/Emg Probe - Tampon | Hollister, Inc. | 1997 | — |
| 0 (this device) | K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/… | Fuji Dynamics, Ltd. | 2016 | — |
| +1 | 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 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K971541 | Vaginal 2 Electrode Stimulation/Emg Probe - TamponSummary page 4…back System Product Code : KPI, HIR Regulatory Class : Class II 3. Predicate Device Information Hollister Vaginal Stimulation/EMG Probe-Tampon (K971541) and Anal Stimulation /EMG Probe-w/Stop (K990456) 4. Device Description The Fuji Dynamics Incontinence Stimulation Electro… | 1997 |
| * | K990456 | Anal 2 Electrode Stimulation/Emg Probe - W/StopSummary page 4…Regulatory Class : Class II 3. Predicate Device Information Hollister Vaginal Stimulation/EMG Probe-Tampon (K971541) and Anal Stimulation /EMG Probe-w/Stop (K990456) 4. Device Description The Fuji Dynamics Incontinence Stimulation Electrode models Fuji-01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210441 | Incontinence Probe | 2021 | 0 |
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 27 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K210441 (Shenzhen Med-Link Electronics Tech Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K971541.
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. 2016, this device’s year, is highlighted.
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 Fuji Dynamics Incontinence Stimulation Electrodes are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week 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/K161055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161055: Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161055
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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