510(k) · Cleared

Cleared

Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer Sensor

K993976510(k) TraditionalCleared Feb 22, 200090-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

The Prometheus Group · KPI Stimulator, Electrical, Non-Implantable, For Incontinence

Cleared on Feb 22, 2000 as substantially equivalent to K974036 (The Prometheus Group, 1997) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1991.

Decided: Feb 22, 2000
Review: 90 days
Class: Class II
Product code: KPI
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K911190 (1991). 4 ancestors in all, the oldest K891773 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK911190 Perrymeter (TM)Perrymeter Systems · 1991
1 generation backK974036 Pathway Vaginal/Rectal Perineometer ProbeThe Prometheus Group · 1997
This deviceK993976 Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim…The Prometheus Group · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K911190	Perrymeter (TM)	Perrymeter Systems	1991	—
−1	K974036	Pathway Vaginal/Rectal Perineometer Probe	The Prometheus Group	1997	—
0 (this device)	K993976	Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim…	The Prometheus Group	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1995	1	0

FIG. 1 — Lineage of K993976, 1991–2000Source: 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? (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	Applicant	Decided	Recalls
*	K974036	Pathway Vaginal/Rectal Perineometer Probe Summary page 2 …n 884.1425) IDENTIFICATION OF PREDICATE DEVICE The device to which we claim substantial equivalence is the Pathway Vaginal/Rectal EMG Perineometer Sensor 510(k) number K974036, the InCare Vaginal EMG/Stimulation Perineometer Sensor and the InCare Anal EMG/Stimulation Perineometer Sensor 510(k) numbers K8…	The Prometheus Group	1997	—
*	K891773	Microgyn II Elec Stim Device Treat of Urin Inconti Summary page 2 …Perineometer Sensor 510(k) number K974036, the InCare Vaginal EMG/Stimulation Perineometer Sensor and the InCare Anal EMG/Stimulation Perineometer Sensor 510(k) numbers K891773 and K930530. The Pathway Vaginal/Rectal EMG Perineometer Sensor, the InCare Vaginal EMG/Stimulation Sensor and the InCare Anal EM…	Hollister, Inc.	1989	—
*	K930530	Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc Summary page 2 …r Sensor 510(k) number K974036, the InCare Vaginal EMG/Stimulation Perineometer Sensor and the InCare Anal EMG/Stimulation Perineometer Sensor 510(k) numbers K891773 and K930530. The Pathway Vaginal/Rectal EMG Perineometer Sensor, the InCare Vaginal EMG/Stimulation Sensor and the InCare Anal EMG/Stimulatio…	Hollister, Inc.	1995	—

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 9 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
None of the 4 ancestors has a recall.

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?

* Urinary Incontinence : Stress, Urge and Mixed Incontinence

* Neuromuscular Reeducation

* Fecal Incontinence (EMG Use only)

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/K993976 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993976: Pathway Vaginal Emg/Stim Perineometer Sensor, Pathway Anal Emg/Stim Perineometer Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993976

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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