Cleared Traditional

K954272 - INNOVA RECTAL STIMULATON ELECTRODE

K954272 is the FDA 510(k) clearance for INNOVA RECTAL STIMULATON ELECTRODE by Empi. It is a Class 2 Gastroenterology & Urology device (product code KPI) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K954272 · Empi · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 1996
Decision
216d
Days
Class 2
Risk

K954272 is an FDA 510(k) clearance for the INNOVA RECTAL STIMULATON ELECTRODE. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Empi (Minneapolis, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 216 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Empi devices

Submission Details

510(k) Number K954272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1995
Decision Date April 15, 1996
Days to Decision 216 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 130d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 47
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K954272.
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)
K964577 · Empi · Jan 1997
MICROGYN PLUS STIMULATION DEVICE
K963222 · Hollister, Inc. · Oct 1996
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K961872 · Hollister, Inc. · Aug 1996
INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
K930530 · Hollister, Inc. · Oct 1995
INNOVA PELVIC FLOOR STIMULATION SYSTEM
K941911 · Empi · Jan 1995
TBD
K910081 · Empi · Jul 1991