510(k) · Cleared

Cleared

Innova Rectal Stimulaton Electrode

K954272510(k) TraditionalCleared Apr 15, 1996216-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

Empi · KPI Stimulator, Electrical, Non-Implantable, For Incontinence

Cleared on Apr 15, 1996 as substantially equivalent to K910081 (Empi, 1991) and 2 other predicates after a 216-day review. Its family tree reaches back 1 generation to 1989. 7 later devices descend from it.

Decided: Apr 15, 1996
Review: 216 days
Class: Class II
Product code: KPI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K891773 (1989). 3 ancestors in all. 7 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK891773 Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc. · 1989
This deviceK954272 Innova Rectal Stimulaton ElectrodeEmpi · 1996
Descendant · cites it directly · 6 of its ownK964577 Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse…Empi · 1997
Descendant · 2 generations on · 3 of its ownK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
Descendant · 3 generations on · 2 of its ownK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
Descendant · 3 generations on · 1 of its ownK020952 Surx RF SystemSurx, Inc. · 2002
Descendant · 4 generations on · 0 of its ownK042132 Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1997high 3 (2002) · low 0 (1999)2026

Most influential descendants

Showing 5 of 7 · See all

K964577Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal…Empi · 1997 · cites it directly6descendants
K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc. · 2002 · 2 generations on3descendants
K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002 · 3 generations on2descendants
K020952Surx RF SystemSurx, Inc. · 2002 · 3 generations on1descendant
K042132Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · 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)	K954272	Innova Rectal Stimulaton Electrode	Empi	1996	—
+1	K964577	Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small…	Empi	1997	—
+2	K011190	Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP…	Surx, Inc.	2002	—
+3	K020126	Modification to Surx Radiofrequency Electrosurgical Generator System and…	Surx, Inc.	2002	—
+3	K020952	Surx RF System	Surx, Inc.	2002	—
+4	K042132	Novasys Transurethral RF System	Novasys Medical, Inc.	2004	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	1	0
2002	3	0
2004	1	0

FIG. 1 — Lineage of K954272, 1989–2004Source: 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
*	K910081	TBD Summary page 1 …Common/Usual Name: Rectal Stimuiation Electrode Trade/Proprietary Name: Innova Rectal Stimmalation Electrode Equivalent Devices: Innova Vaginal Stimulation Electrode (K910081,K940031) InCare Rectal Electrode (K891773) Product Description: The Innova Rectal Stimplation Electrode assembly is a light-wei…	Empi	1991	—
*	K940091	Innova Vaginal Emg Sensing Electrode Summary page 2 …E SPECIFICATIONS TO PREDICATE DEVICES & 'ég SRR S ?fgﬁﬁﬁ,;e e A Premarket Stimulation - K891773 Stimr.ulation - K910081 Notification EMG Sensing - K891774 EMG Sensing - K940091 Number Of 2 - Stimulation 3 - Sensing Electrodes 4 - Stimulation Biocompatibility Unknown Mcets the Tripartite Guidance and USP c…	Empi	1994	—
*	K891773	Microgyn II Elec Stim Device Treat of Urin Inconti Summary page 1 …ctrode Trade/Proprietary Name: Innova Rectal Stimmalation Electrode Equivalent Devices: Innova Vaginal Stimulation Electrode (K910081,K940031) InCare Rectal Electrode (K891773) Product Description: The Innova Rectal Stimplation Electrode assembly is a light-weight cylinder consisting of two conductive…	Hollister, Inc.	1989	—

Also cleared against K910081: 2 other devices →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K964577	Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal…	Empi	1997	6
K983206	Small Vaginal/Rectal Electrode	Empi	1998	0
K972054	Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable Electrode	Empi	1997	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?

None of the 3 ancestors has a recall.
Of its descendants, K964577 (Empi, 1997) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K910081.

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?

The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for 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/K954272 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954272: Innova Rectal Stimulaton Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954272

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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