Cleared Traditional

K834311 - NIGHT TRAINER

K834311 is an FDA 510(k) clearance for NIGHT TRAINER, manufactured by Maddak, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPN cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K834311 · Maddak, Inc. · Gastroenterology & Urology device
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Mar 1984
Decision
126d
Days
Class 2
Risk

K834311 is an FDA 510(k) clearance for the NIGHT TRAINER. Classified as Alarm, Conditioned Response Enuresis (product code KPN), Class II - Special Controls.

Submitted by Maddak, Inc. (Walker, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 126 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.

FDA 510(k) Submission Details - K834311

510(k) Number K834311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date March 30, 1984
Days to Decision 126 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
5d faster than avg
Panel avg: 131d · This submission: 126d
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 K834311.
NYTONE ENURETIC ALARM BEDWETTING DEVICE
K844866 · Nytone Medical · Apr 1985
BED SENTRY, MODEL 50U
K850538 · Metatech Corp. · Apr 1985
WET-STOP
K842547 · Palco Laboratories, Inc. · Oct 1984
BED GUARD
K823276 · T. S. Enterprises, Inc. · Nov 1982
MONITORING DEVICE ENURESIS ALARM & ACC.
K821546 · Wetbell, Inc. · Jun 1982
DETECTOR PAD
K782093 · Halperin Institute, Ltd. The · Feb 1979
K834311 · NIGHT TRAINER
Download PDF Maddak, Inc.