Cleared Traditional

K013653 - INCARE PRESSURE BIOFEEDBACK VAGINAL PRE...

K013653 is an FDA 510(k) clearance for INCARE PRESSURE BIOFEEDBACK VAGINAL PRE..., manufactured by Hollister, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K013653 · Hollister, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2002
Decision
119d
Days
Class 2
Risk

K013653 is an FDA 510(k) clearance for the INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on March 5, 2002 after a review of 119 days - within the typical 510(k) review window.

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 Hollister, Inc. devices

FDA 510(k) Submission Details - K013653

510(k) Number K013653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date March 05, 2002
Days to Decision 119 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
11d faster than avg
Panel avg: 130d · This submission: 119d
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 21
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K013653.
LEva Pelvic Digital Health System
K192270 · Renovia, Inc. · Nov 2019
leva Pelvic Floor Trainer
K180637 · Renovia, Inc. · Apr 2018
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · 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