Cleared Traditional

K921431 - POTTY PAGER

K921431 is an FDA 510(k) clearance for POTTY PAGER, manufactured by Ideas For Living. The device is a Class 2 Gastroenterology & Urology device with product code KPN cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K921431 · Ideas For Living · Gastroenterology & Urology device
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Jul 1992
Decision
118d
Days
Class 2
Risk

K921431 is an FDA 510(k) clearance for the POTTY PAGER. Classified as Alarm, Conditioned Response Enuresis (product code KPN), Class II - Special Controls.

Submitted by Ideas For Living (Boulder, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 118 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.

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FDA 510(k) Submission Details - K921431

510(k) Number K921431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1992
Decision Date July 21, 1992
Days to Decision 118 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 130d · This submission: 118d
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.