Cleared Traditional

K854193 - ELECTRO-MYOGRAPHIC PERINEOMETER

K854193 is an FDA 510(k) clearance for ELECTRO-MYOGRAPHIC PERINEOMETER, manufactured by Verimed Holdings, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K854193 · Verimed Holdings, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
237d
Days
Class 2
Risk

K854193 is an FDA 510(k) clearance for the ELECTRO-MYOGRAPHIC 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 9, 1986 after a review of 237 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.

FDA 510(k) Submission Details - K854193

510(k) Number K854193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date June 09, 1986
Days to Decision 237 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 131d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIR Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K854193.
CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI
K891774 · Hollister, Inc. · Aug 1989
VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363
K861858 · Peritone Research, Ltd. · Jul 1986
MILEX KEGEL PERINEAL EXERCISER
K862410 · Milex Products, Inc. · Jul 1986
MONSANTO SANTOPRENE (PERITONE DEVICE)
K861683 · Peritone Research, Ltd. · Jun 1986
PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
K860552 · Laurie Ann Kaiser, Ph.D. · Apr 1986
PP-100, PERSONAL PERINEOMETER
K821664 · Farrall Instruments, Inc. · Jul 1982
K854193 · ELECTRO-MYOGRAPHIC PERINEOMETER
Download PDF Verimed Holdings, Inc.