KPN · Class II · 21 CFR 876.2040

FDA Product Code KPN: Alarm, Conditioned Response Enuresis

Leading manufacturers include Health Sense Intl., Inc., Biosonics, Inc. and Travis Industries, Inc..

37
Total
37
Cleared
112d
Avg days
1978
Since

FDA 510(k) Cleared Alarm, Conditioned Response Enuresis Devices (Product Code KPN)

37 devices
1–24 of 37
Cleared Aug 22, 2013
SIM
K130951
Simavita Pty Limited
Gastroenterology & Urology · 139d
Cleared Jan 08, 1998
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.
Gastroenterology & Urology · 262d
Cleared Aug 18, 1997
POTTY PAL AND FOREVER-DRY
K971855
Digital Applications, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 01, 1996
UROSURGE ACUTRAINER
K962770
Princeton Regulatory Assoc.
Gastroenterology & Urology · 16d
Cleared Jul 22, 1996
DRYTIME FOR BLADDER CONTROL SILENT
K962416
Bio-Systems Research
Gastroenterology & Urology · 83d
Cleared Mar 12, 1996
DRYTIME FOR POTTY TRAINING
K955338
Health Sense Intl., Inc.
Gastroenterology & Urology · 112d
Cleared May 24, 1995
PRO'TECT
K943558
Health Sense Intl., Inc.
Gastroenterology & Urology · 306d
Cleared May 24, 1995
REMOTE A'LERT
K943559
Health Sense Intl., Inc.
Gastroenterology & Urology · 306d
Cleared Jul 28, 1994
FISHER-PRICE DRY NIGHT MONITOR
K942057
Fisher Price
Gastroenterology & Urology · 91d
Cleared May 13, 1994
WET SENSE
K935915
Edson Corp.
Gastroenterology & Urology · 155d
Cleared Nov 24, 1993
DRI SLEEPER
K934369
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 78d
Cleared Mar 03, 1993
DRITRAINER
K930005
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 58d
Cleared Jul 21, 1992
POTTY PAGER
K921431
Ideas For Living
Gastroenterology & Urology · 118d
Cleared Sep 04, 1991
DRY TIME
K911279
Health Sense Intl., Inc.
Gastroenterology & Urology · 163d
Cleared Sep 12, 1990
PROFESSIONAL MONITOR
K901907
Travis Industries, Inc.
Gastroenterology & Urology · 138d
Cleared Sep 12, 1990
WET-NO-MORE MONITOR
K903856
Travis Industries, Inc.
Gastroenterology & Urology · 50d
Cleared Jul 11, 1990
WET-NO-MORE MONITOR
K901906
Travis Industries, Inc.
Gastroenterology & Urology · 75d
Cleared Feb 12, 1990
BUZZY BEAR ENURESIS ALARM
K895852
Med-Design, Inc.
Gastroenterology & Urology · 132d
Cleared Nov 13, 1989
BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
K895251
C.R. Bard, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 24, 1989
DR. DRY
K895346
Intellitech
Gastroenterology & Urology · 53d
Cleared May 24, 1989
HEALTHSHIELD
K885345
Jonas, Inc.
Gastroenterology & Urology · 147d
Cleared Aug 30, 1988
ANOTRON(R) INCONTINENCE CONTROL SYSTEM
K882555
Biosonics, Inc.
Gastroenterology & Urology · 70d
Cleared Jan 19, 1988
BED ALERT
K872522
Nite Train-R Enterprises, Inc.
Gastroenterology & Urology · 208d
Cleared Aug 10, 1987
ENURESIS ALARM
K871787
Dilorenzo Engineering Co.
Gastroenterology & Urology · 96d

About Product Code KPN - Regulatory Context