Cleared Traditional

K972054 - INNOVA RECTAL REUSABLE ELECTRODE/COMFOR...

K972054 is the FDA 510(k) clearance for INNOVA RECTAL REUSABLE ELECTRODE/COMFOR... by Empi. It is a Class 2 Gastroenterology & Urology device (product code KPI) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K972054 · Empi · Gastroenterology & Urology device
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Aug 1997
Decision
73d
Days
Class 2
Risk

K972054 is an FDA 510(k) clearance for the INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECT.... Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Empi (St. Paul, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Empi devices

Submission Details

510(k) Number K972054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date August 14, 1997
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
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 K972054.
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
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SMALL VAGINAL/RECTAL ELECTRODE
K983206 · Empi · Nov 1998
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K974048 · Hollister, Inc. · Dec 1997
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
K971527 · Empi · Jun 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
K971541 · Hollister, Inc. · Jun 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
K970307 · Empi · Apr 1997