Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KPN — Predicate Candidate Screening

37 FDA 510(k) clearances under this product code; the 50 most recent screened below.

99 daysmedian FDA review time

208 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days
K130951	SIM	Simavita Pty Limited	2013-08-22	139
K971442	HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED	Humed, Inc.	1998-01-08	262
K971855	POTTY PAL AND FOREVER-DRY	Digital Applications, Inc.	1997-08-18	90
K962770	UROSURGE ACUTRAINER	Princeton Regulatory Assoc.	1996-08-01	16
K962416	DRYTIME FOR BLADDER CONTROL SILENT	Bio-Systems Research	1996-07-22	83
K955338	DRYTIME FOR POTTY TRAINING	Health Sense Intl., Inc.	1996-03-12	112
K943558	PRO'TECT	Health Sense Intl., Inc.	1995-05-24	306
K943559	REMOTE A'LERT	Health Sense Intl., Inc.	1995-05-24	306
K942057	FISHER-PRICE DRY NIGHT MONITOR	Fisher Price	1994-07-28	91
K935915	WET SENSE	Edson Corp.	1994-05-13	155
K934369	DRI SLEEPER	Laborie Medical Technologies, Ltd.	1993-11-24	78
K930005	DRITRAINER	Laborie Medical Technologies, Ltd.	1993-03-03	58
K921431	POTTY PAGER	Ideas For Living	1992-07-21	118
K911279	DRY TIME	Health Sense Intl., Inc.	1991-09-04	163
K903856	WET-NO-MORE MONITOR	Travis Industries, Inc.	1990-09-12	50
K901907	PROFESSIONAL MONITOR	Travis Industries, Inc.	1990-09-12	138
K901906	WET-NO-MORE MONITOR	Travis Industries, Inc.	1990-07-11	75
K895852	BUZZY BEAR ENURESIS ALARM	Med-Design, Inc.	1990-02-12	132
K895251	BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))	C.R. Bard, Inc.	1989-11-13	84
K895346	DR. DRY	Intellitech	1989-10-24	53
K885345	HEALTHSHIELD	Jonas, Inc.	1989-05-24	147
K882555	ANOTRON(R) INCONTINENCE CONTROL SYSTEM	Biosonics, Inc.	1988-08-30	70
K872522	BED ALERT	Nite Train-R Enterprises, Inc.	1988-01-19	208
K871787	ENURESIS ALARM	Dilorenzo Engineering Co.	1987-08-10	96
K864448	THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM)	Biosonics, Inc.	1987-02-06	86
K862683	BIOSOICS SPHINCTER TRAINING SYSTEM	Biosonics, Inc.	1986-11-12	120
K862757	STARCHILD SLEEPDRY	Starchild, Inc.	1986-10-29	99
K854539	UROSTAT	Urologics, Inc.	1986-02-04	83
K844866	NYTONE ENURETIC ALARM BEDWETTING DEVICE	Nytone Medical	1985-04-03	110
K844636	SENTRY SIGNAL ENURESIS ALARM SYSTEM	Conklin Technology, Inc.	1985-04-03	126
K850538	BED SENTRY, MODEL 50U	Metatech Corp.	1985-04-03	51
K842547	WET-STOP	Palco Laboratories, Inc.	1984-10-19	109
K834311	NIGHT TRAINER	Maddak, Inc.	1984-03-30	126
K823276	BED GUARD	T. S. Enterprises, Inc.	1982-11-24	21
K821546	MONITORING DEVICE ENURESIS ALARM & ACC.	Wetbell, Inc.	1982-06-09	15
K782093	DETECTOR PAD	Halperin Institute, Ltd. The	1979-02-21	69
K780660	NITE TRAIN'R	Nite Train-R Enterprises, Inc.	1978-07-28	99

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda