Cleared Traditional

K962770 - UROSURGE ACUTRAINER

K962770 is an FDA 510(k) clearance for UROSURGE ACUTRAINER, manufactured by Princeton Regulatory Assoc.. The device is a Class 2 Gastroenterology & Urology device with product code KPN cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K962770 · Princeton Regulatory Assoc. · Gastroenterology & Urology device
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Aug 1996
Decision
16d
Days
Class 2
Risk

K962770 is an FDA 510(k) clearance for the UROSURGE ACUTRAINER. Classified as Alarm, Conditioned Response Enuresis (product code KPN), Class II - Special Controls.

Submitted by Princeton Regulatory Assoc. (Princeton, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 16 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.

View all Princeton Regulatory Assoc. devices

FDA 510(k) Submission Details - K962770

510(k) Number K962770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1996
Decision Date August 01, 1996
Days to Decision 16 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 131d · This submission: 16d
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 7
Devices cleared under the same product code (KPN) and FDA review panel - the closest regulatory comparables to K962770.
SIM
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DRYTIME FOR POTTY TRAINING
K955338 · Health Sense Intl., Inc. · Mar 1996
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