Cleared Traditional

K942057 - FISHER-PRICE DRY NIGHT MONITOR

K942057 is an FDA 510(k) clearance for FISHER-PRICE DRY NIGHT MONITOR, manufactured by Fisher Price. The device is a Class 2 Gastroenterology & Urology device with product code KPN cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K942057 · Fisher Price · Gastroenterology & Urology device
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Jul 1994
Decision
91d
Days
Class 2
Risk

K942057 is an FDA 510(k) clearance for the FISHER-PRICE DRY NIGHT MONITOR. Classified as Alarm, Conditioned Response Enuresis (product code KPN), Class II - Special Controls.

Submitted by Fisher Price (East Aurora, US). The FDA issued a Cleared decision on July 28, 1994 after a review of 91 days - within the typical 510(k) review window.

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: 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 Fisher Price devices

FDA 510(k) Submission Details - K942057

510(k) Number K942057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date July 28, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 131d · This submission: 91d
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 8
Devices cleared under the same product code (KPN) and FDA review panel - the closest regulatory comparables to K942057.
UROSURGE ACUTRAINER
K962770 · Princeton Regulatory Assoc. · Aug 1996
DRYTIME FOR BLADDER CONTROL SILENT
K962416 · Bio-Systems Research · Jul 1996
DRYTIME FOR POTTY TRAINING
K955338 · Health Sense Intl., Inc. · Mar 1996
BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
K895251 · C.R. Bard, Inc. · Nov 1989
NIGHT TRAINER
K834311 · Maddak, Inc. · Mar 1984