Product Code: KPN FDA class 2 21 CFR 876.2040

Alarm, Conditioned Response Enuresis

Gastroenterology, Urology

This device is a conditioned response enuresis alarm, commonly known as a bedwetting alarm, which detects moisture and produces an auditory or vibratory signal to awaken the user and help train bladder control. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPN, regulated under 21 CFR 876.2040 within the Gastroenterology and Urology specialty. No special flags apply.

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FEI Numbers

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Basic Information

Product Code: KPN
Device Class: FDA class 2
Regulation Number: 876.2040
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130951	SIM	Aug 22, 2013	Substantially Equivalent	Simavita Pty Limited
K971442	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	Jan 08, 1998	Substantially Equivalent	Humed, Inc.
K971855	POTTY PAL AND FOREVER-DRY	Aug 18, 1997	Substantially Equivalent	Digital Applications, Inc.
K962770	UROSURGE ACUTRAINER	Aug 01, 1996	Substantially Equivalent	Princeton Regulatory Assoc.
K962416	DRYTIME FOR BLADDER CONTROL SILENT	Jul 22, 1996	Substantially Equivalent	Bio-Systems Research
K955338	DRYTIME FOR POTTY TRAINING	Mar 12, 1996	Substantially Equivalent	Health Sense Intl., Inc.
K943559	REMOTE A'LERT	May 24, 1995	Substantially Equivalent	Health Sense Intl., Inc.
K943558	PRO'TECT	May 24, 1995	Substantially Equivalent	Health Sense Intl., Inc.
K942057	FISHER-PRICE DRY NIGHT MONITOR	Jul 28, 1994	Substantially Equivalent	Fisher Price
K935915	WET SENSE	May 13, 1994	Substantially Equivalent	Edson Corp.
K934369	DRI SLEEPER	Nov 24, 1993	Substantially Equivalent	Laborie Medical Technologies, Ltd.
K930005	DRITRAINER	Mar 03, 1993	Substantially Equivalent	Laborie Medical Technologies, Ltd.
K921431	POTTY PAGER	Jul 21, 1992	Substantially Equivalent	Ideas For Living
K911279	DRY TIME	Sep 04, 1991	Substantially Equivalent	Health Sense Intl., Inc.
K903856	WET-NO-MORE MONITOR	Sep 12, 1990	Substantially Equivalent	Travis Industries, Inc.
K901907	PROFESSIONAL MONITOR	Sep 12, 1990	Substantially Equivalent	Travis Industries, Inc.
K901906	WET-NO-MORE MONITOR	Jul 11, 1990	Substantially Equivalent	Travis Industries, Inc.
K895852	BUZZY BEAR ENURESIS ALARM	Feb 12, 1990	Substantially Equivalent	Med-Design, Inc.
K895251	BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))	Nov 13, 1989	Substantially Equivalent	C.R. Bard, Inc.
K895346	DR. DRY	Oct 24, 1989	Substantially Equivalent	Intellitech
K885345	HEALTHSHIELD	May 24, 1989	Substantially Equivalent	Jonas, Inc.
K882555	ANOTRON(R) INCONTINENCE CONTROL SYSTEM	Aug 30, 1988	Substantially Equivalent	Biosonics, Inc.
K872522	BED ALERT	Jan 19, 1988	Substantially Equivalent	Nite Train-R Enterprises, Inc.
K871787	ENURESIS ALARM	Aug 10, 1987	Substantially Equivalent	Dilorenzo Engineering Co.
K864448	THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM)	Feb 06, 1987	Substantially Equivalent	Biosonics, Inc.
K862683	BIOSOICS SPHINCTER TRAINING SYSTEM	Nov 12, 1986	Substantially Equivalent	Biosonics, Inc.
K862757	STARCHILD SLEEPDRY	Oct 29, 1986	Substantially Equivalent	Starchild, Inc.
K854539	UROSTAT	Feb 04, 1986	Substantially Equivalent	Urologics, Inc.
K850538	BED SENTRY, MODEL 50U	Apr 03, 1985	Substantially Equivalent	Metatech Corp.
K844866	NYTONE ENURETIC ALARM BEDWETTING DEVICE	Apr 03, 1985	Substantially Equivalent	Nytone Medical
K844636	SENTRY SIGNAL ENURESIS ALARM SYSTEM	Apr 03, 1985	Substantially Equivalent	Conklin Technology, Inc.
K842547	WET-STOP	Oct 19, 1984	Substantially Equivalent	Palco Laboratories, Inc.
K834311	NIGHT TRAINER	Mar 30, 1984	Substantially Equivalent	Maddak, Inc.
K823276	BED GUARD	Nov 24, 1982	Substantially Equivalent	T. S. Enterprises, Inc.
K821546	MONITORING DEVICE ENURESIS ALARM & ACC.	Jun 09, 1982	Substantially Equivalent	Wetbell, Inc.
K782093	DETECTOR PAD	Feb 21, 1979	Substantially Equivalent	Halperin Institute, Ltd. The
K780660	NITE TRAIN'R	Jul 28, 1978	Substantially Equivalent	Nite Train-R Enterprises, Inc.