Atlas FDA

KPN

37 FDA 510(k) clearances · Product code

99 daysmedian time to decision
208 days90th percentile
37clearances measured

FDA profile

Official device name
Alarm, Conditioned Response Enuresis
Device class
Class II (moderate risk)
Regulation
21 CFR 876.2040
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2015: 9 · 2016: 21 · 2017: 185 · 2018: 286 · 2019: 423 · 2020: 36
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SIM (K130951)Simavita Pty Limited2013-08-22
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.1998-01-08
POTTY PAL AND FOREVER-DRY (K971855)Digital Applications, Inc.1997-08-18
UROSURGE ACUTRAINER (K962770)Princeton Regulatory Assoc.1996-08-01
DRYTIME FOR BLADDER CONTROL SILENT (K962416)Bio-Systems Research1996-07-22
DRYTIME FOR POTTY TRAINING (K955338)Health Sense Intl., Inc.1996-03-12
PRO'TECT (K943558)Health Sense Intl., Inc.1995-05-24
REMOTE A'LERT (K943559)Health Sense Intl., Inc.1995-05-24
FISHER-PRICE DRY NIGHT MONITOR (K942057)Fisher Price1994-07-28
WET SENSE (K935915)Edson Corp.1994-05-13
DRI SLEEPER (K934369)Laborie Medical Technologies, Ltd.1993-11-24
DRITRAINER (K930005)Laborie Medical Technologies, Ltd.1993-03-03
POTTY PAGER (K921431)Ideas For Living1992-07-21
DRY TIME (K911279)Health Sense Intl., Inc.1991-09-04
WET-NO-MORE MONITOR (K903856)Travis Industries, Inc.1990-09-12
PROFESSIONAL MONITOR (K901907)Travis Industries, Inc.1990-09-12
WET-NO-MORE MONITOR (K901906)Travis Industries, Inc.1990-07-11
BUZZY BEAR ENURESIS ALARM (K895852)Med-Design, Inc.1990-02-12
BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) (K895251)C.R. Bard, Inc.1989-11-13
DR. DRY (K895346)Intellitech1989-10-24
HEALTHSHIELD (K885345)Jonas, Inc.1989-05-24
ANOTRON(R) INCONTINENCE CONTROL SYSTEM (K882555)Biosonics, Inc.1988-08-30
BED ALERT (K872522)Nite Train-R Enterprises, Inc.1988-01-19
ENURESIS ALARM (K871787)Dilorenzo Engineering Co.1987-08-10
THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM) (K864448)Biosonics, Inc.1987-02-06
BIOSOICS SPHINCTER TRAINING SYSTEM (K862683)Biosonics, Inc.1986-11-12
STARCHILD SLEEPDRY (K862757)Starchild, Inc.1986-10-29
UROSTAT (K854539)Urologics, Inc.1986-02-04
NYTONE ENURETIC ALARM BEDWETTING DEVICE (K844866)Nytone Medical1985-04-03
SENTRY SIGNAL ENURESIS ALARM SYSTEM (K844636)Conklin Technology, Inc.1985-04-03
BED SENTRY, MODEL 50U (K850538)Metatech Corp.1985-04-03
WET-STOP (K842547)Palco Laboratories, Inc.1984-10-19
NIGHT TRAINER (K834311)Maddak, Inc.1984-03-30
BED GUARD (K823276)T. S. Enterprises, Inc.1982-11-24
MONITORING DEVICE ENURESIS ALARM & ACC. (K821546)Wetbell, Inc.1982-06-09
DETECTOR PAD (K782093)Halperin Institute, Ltd. The1979-02-21
NITE TRAIN'R (K780660)Nite Train-R Enterprises, Inc.1978-07-28

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Every clearance here is in the API, with alerts when new ones post.