Cleared Traditional

K895251 - BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))

K895251 is an FDA 510(k) clearance for BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)), manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K895251 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Nov 1989
Decision
84d
Days
Class 2
Risk

K895251 is an FDA 510(k) clearance for the BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)). Classified as Alarm, Conditioned Response Enuresis (product code KPN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on November 13, 1989 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.2040 - 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.

FDA 510(k) Submission Details - K895251

510(k) Number K895251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1989
Decision Date November 13, 1989
Days to Decision 84 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
47d faster than avg
Panel avg: 131d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPN Device Classification - Class 2, Special Controls

Product Code KPN Alarm, Conditioned Response Enuresis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.2040
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 - KPN Alarm, Conditioned Response Enuresis

All 36
Devices cleared under the same product code (KPN) and FDA review panel - the closest regulatory comparables to K895251.
WET-NO-MORE MONITOR
K903856 · Travis Industries, Inc. · Sep 1990
WET-NO-MORE MONITOR
K901906 · Travis Industries, Inc. · Jul 1990
BUZZY BEAR ENURESIS ALARM
K895852 · Med-Design, Inc. · Feb 1990
DR. DRY
K895346 · Intellitech · Oct 1989
HEALTHSHIELD
K885345 · Jonas, Inc. · May 1989
ANOTRON(R) INCONTINENCE CONTROL SYSTEM
K882555 · Biosonics, Inc. · Aug 1988
K895251 · BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
Download PDF C.R. Bard, Inc.