Cleared Traditional

K913912 - VERIMED PERINEOMETER

K913912 is the FDA 510(k) clearance for VERIMED PERINEOMETER by Verimed Holdings, Inc.. It is a Class 2 Gastroenterology & Urology device (product code HIR) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K913912 · Verimed Holdings, Inc. · Gastroenterology & Urology device
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Jun 1992
Decision
292d
Days
Class 2
Risk

K913912 is an FDA 510(k) clearance for the VERIMED PERINEOMETER. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Verimed Holdings, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on June 16, 1992 after a review of 292 days - an extended review cycle.

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. 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 Verimed Holdings, Inc. devices

Submission Details

510(k) Number K913912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1991
Decision Date June 16, 1992
Days to Decision 292 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 130d · This submission: 292d
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 22
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K913912.
PERINEOMETER
K960311 · Hollister, Inc. · Apr 1996
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE
K952688 · Empi · Dec 1995
INNOVA VAGINAL EMG SENSING ELECTRODE
K940091 · Empi · Dec 1994
EXTACISER PERINEAL MUSCLE EXERCISER
K892888 · Bivona Medical Technologies · Oct 1989
CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI
K891774 · Hollister, Inc. · Aug 1989