Cleared Traditional

K990456 - ANAL 2 ELECTRODE STIMULATION/EMG PROBE ...

K990456 is an FDA 510(k) clearance for ANAL 2 ELECTRODE STIMULATION/EMG PROBE ..., manufactured by Hollister, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K990456 · Hollister, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
41d
Days
Class 2
Risk

K990456 is an FDA 510(k) clearance for the ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on March 25, 1999 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K990456

510(k) Number K990456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1999
Decision Date March 25, 1999
Days to Decision 41 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
89d faster than avg
Panel avg: 130d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 53
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K990456.
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MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc. · Dec 2001
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · Empi · Nov 1998
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K974048 · Hollister, Inc. · Dec 1997
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
K972054 · Empi · Aug 1997