Cleared Traditional

K002617 - PERIFORM PERINEOMETRIC PROBE

K002617 is an FDA 510(k) clearance for PERIFORM PERINEOMETRIC PROBE, manufactured by Neen Design , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K002617 · Neen Design , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
225d
Days
Class 2
Risk

K002617 is an FDA 510(k) clearance for the PERIFORM PERINEOMETRIC PROBE, MODEL 8300. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Neen Design , Ltd. (Dereham, Norfolk, GB). The FDA issued a Cleared decision on April 5, 2001 after a review of 225 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 Neen Design , Ltd. devices

FDA 510(k) Submission Details - K002617

510(k) Number K002617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2000
Decision Date April 05, 2001
Days to Decision 225 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 130d · This submission: 225d
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 22
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K002617.
leva Pelvic Floor Trainer
K180637 · Renovia, Inc. · Apr 2018
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · Hollister, Inc. · Mar 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653 · Hollister, Inc. · Mar 2002
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