Cleared Traditional

K962416 - DRYTIME FOR BLADDER CONTROL SILENT

K962416 is an FDA 510(k) clearance for DRYTIME FOR BLADDER CONTROL SILENT, manufactured by Bio-Systems Research. The device is a Class 2 Gastroenterology & Urology device with product code KPN cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K962416 · Bio-Systems Research · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
83d
Days
Class 2
Risk

K962416 is an FDA 510(k) clearance for the DRYTIME FOR BLADDER CONTROL SILENT. Classified as Alarm, Conditioned Response Enuresis (product code KPN), Class II - Special Controls.

Submitted by Bio-Systems Research (Lake Oswego, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 83 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 Bio-Systems Research devices

FDA 510(k) Submission Details - K962416

510(k) Number K962416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1996
Decision Date July 22, 1996
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 131d · This submission: 83d
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 K962416.
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5
K971442 · Humed, Inc. · Jan 1998
POTTY PAL AND FOREVER-DRY
K971855 · Digital Applications, Inc. · Aug 1997
UROSURGE ACUTRAINER
K962770 · Princeton Regulatory Assoc. · Aug 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