Cleared Traditional

K940091 - INNOVA VAGINAL EMG SENSING ELECTRODE

K940091 is the FDA 510(k) clearance for INNOVA VAGINAL EMG SENSING ELECTRODE by Empi. It is a Class 2 Gastroenterology & Urology device (product code HIR) cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K940091 · Empi · Gastroenterology & Urology device
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Dec 1994
Decision
356d
Days
Class 2
Risk

K940091 is an FDA 510(k) clearance for the INNOVA VAGINAL EMG SENSING ELECTRODE. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - 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. Elevated predicate reliance profile. 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 K940091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1994
Decision Date December 29, 1994
Days to Decision 356 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
226d slower than avg
Panel avg: 130d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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 - HIR Perineometer

All 21
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K940091.
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · Biosearch Medical Products, Inc. · Aug 1997
PERINEOMETER
K960311 · Hollister, Inc. · Apr 1996
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE
K952688 · Empi · Dec 1995
EXTACISER PERINEAL MUSCLE EXERCISER
K892888 · Bivona Medical Technologies · Oct 1989
CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI
K891774 · Hollister, Inc. · Aug 1989