Cleared Traditional

K002834 - SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR

K002834 is an FDA 510(k) clearance for SRS VAGINAL EMG/STIMULATION PERINEOMETE..., manufactured by Srs Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K002834 · Srs Medical Systems, Inc. · Gastroenterology & Urology device
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Nov 2000
Decision
78d
Days
Class 2
Risk

K002834 is an FDA 510(k) clearance for the SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERI.... Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Srs Medical Systems, Inc. (Redmond, US). The FDA issued a Cleared decision on November 29, 2000 after a review of 78 days - a notably fast clearance 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: 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 Srs Medical Systems, Inc. devices

FDA 510(k) Submission Details - K002834

510(k) Number K002834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2000
Decision Date November 29, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 131d · This submission: 78d
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 49
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K002834.
PELVEX HOMETRAINER
K002043 · Purdue Technology Park · May 2001
PERIFORM PERINEOMETRIC PROBE, MODEL 8300
K002617 · Neen Design , Ltd. · Apr 2001
PELVIC MUSCLE THERAPY
K002830 · Colonial Medical Supply · Dec 2000
REFLEX TREATMENT SYSTEM
K994079 · Deschutes Medical Products, Inc. · Mar 2000
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
K993411 · Mega Electronics , Ltd. · Jan 2000
PERIFORM
K981277 · Verimed Holdings, Inc. · Nov 1998