510(k) · Cleared

Cleared

Vaginal 2 Electrode Stimulation/Emg Probe-Small

K970602510(k) TraditionalCleared Apr 15, 199756-day reviewClass II21 CFR 876.5320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hollister, Inc. · KPI Stimulator, Electrical, Non-Implantable, For Incontinence

Cleared on Apr 15, 1997 as substantially equivalent to K891773 (Hollister, Inc., 1989) after a 56-day review. Its family tree reaches back 1 generation to 1989. 7 later devices descend from it.

Decided: Apr 15, 1997
Review: 56 days
Class: Class II
Product code: KPI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K891773 (1989). 7 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
This deviceK970602 Vaginal 2 Electrode Stimulation/Emg Probe-SmallHollister, Inc. · 1997
Descendant · cites it directly · 6 of its ownK971541 Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc. · 1997
Descendant · 2 generations on · 3 of its ownK122194 Life-Care Vaginal Probe Life-Care Anal ProbeEveryway Medical Instruments Co.,Ltd · 2013
Descendant · 3 generations on · 1 of its ownK222528 Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA)…Well-Life Healthcare Limited · 2022
Descendant · 2 generations on · 1 of its ownK161055 Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/…Fuji Dynamics, Ltd. · 2016
Descendant · 4 generations on · 0 of its ownK231166 Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic…Zmi Electronics, Ltd. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1997high 1 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 7 · See all

K971541Vaginal 2 Electrode Stimulation/Emg Probe - TamponHollister, Inc. · 1997 · cites it directly6descendants
K122194Life-Care Vaginal Probe Life-Care Anal ProbeEveryway Medical Instruments Co.,Ltd · 2013 · 2 generations on3descendants
K222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence…Well-Life Healthcare Limited · 2022 · 3 generations on1descendant
K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/…Fuji Dynamics, Ltd. · 2016 · 2 generations on1descendant
K231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe…Zmi Electronics, Ltd. · 2024 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891773	Microgyn II Elec Stim Device Treat of Urin Inconti	Hollister, Inc.	1989	—
0 (this device)	K970602	Vaginal 2 Electrode Stimulation/Emg Probe-Small	Hollister, Inc.	1997	—
+1	K971541	Vaginal 2 Electrode Stimulation/Emg Probe - Tampon	Hollister, Inc.	1997	—
+2	K122194	Life-Care Vaginal Probe Life-Care Anal Probe	Everyway Medical Instruments Co.,Ltd	2013	—
+3	K222528	Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life…	Well-Life Healthcare Limited	2022	—
+2	K161055	Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/…	Fuji Dynamics, Ltd.	2016	—
+4	K231166	Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor…	Zmi Electronics, Ltd.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2013	1	0
2015	1	0
2016	1	0
2021	1	0
2022	1	0
2024	1	0

FIG. 1 — Lineage of K970602, 1989–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K891773	Microgyn II Elec Stim Device Treat of Urin Inconti Summary page 1 …8-3860 Date Summary Prepared - February 13, 1997 2. Name of Device: Vaginal Stimulation/EMG Probe - Small 3. Name of Predicate Device(s) Vaginal Stimulation/EMG Probe, K891773 4. Description of Device ( Hollister Incorporated through it’s InCare Division currently markets a vaginal 2-electrode stimulat…	Hollister, Inc.	1989	—

Also cleared against K891773: 8 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K971541	Vaginal 2 Electrode Stimulation/Emg Probe - Tampon	Hollister, Inc.	1997	6

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?

Its one ancestor has no recall.
Of its descendants, K971541 (Hollister, Inc., 1997) has gone furthest, with 6 descendants of its own.
8 other devices also cite its predicate K891773.

How does its category compare?

All KPI devices

KPI 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

2007high 7 (2026) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPI

263in 2025

2007high 304 (2018) · low 57 (2014)2026

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

2007high 6 (2023) · low 0 (2007)2025

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	MAUDE reports
2007	1	—	0
2008	1	—	0
2009	2	—	0
2010	0	—	0
2011	1	—	0
2012	2	—	0
2013	1	—	1
2014	3	57	0
2015	6	260	2
2016	3	89	0
2017	1	—	4
2018	3	304	0
2019	2	—	2
2020	1	—	3
2021	3	217	1
2022	3	181	2
2023	3	197	6
2024	4	172	2
2025	4	263	0
2026	7	248	—

What is it indicated for?

Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. EMG sensing 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/K970602 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970602: Vaginal 2 Electrode Stimulation/Emg Probe-Small.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970602

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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