Product code KPN
- Device name
- Alarm, Conditioned Response Enuresis
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.2040
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130951 | SIM | Simavita Pty Limited | 2013-08-22 |
| 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 | Humed, Inc. | 1998-01-08 |
| K971855 | POTTY PAL AND FOREVER-DRY | Digital Applications, Inc. | 1997-08-18 |
| K962770 | UROSURGE ACUTRAINER | Princeton Regulatory Assoc. | 1996-08-01 |
| K962416 | DRYTIME FOR BLADDER CONTROL SILENT | Bio-Systems Research | 1996-07-22 |
| K955338 | DRYTIME FOR POTTY TRAINING | Health Sense Intl., Inc. | 1996-03-12 |
| K943559 | REMOTE A'LERT | Health Sense Intl., Inc. | 1995-05-24 |
| K943558 | PRO'TECT | Health Sense Intl., Inc. | 1995-05-24 |
| K942057 | FISHER-PRICE DRY NIGHT MONITOR | Fisher Price | 1994-07-28 |
| K935915 | WET SENSE | Edson Corp. | 1994-05-13 |
| K934369 | DRI SLEEPER | Laborie Medical Technologies, Ltd. | 1993-11-24 |
| K930005 | DRITRAINER | Laborie Medical Technologies, Ltd. | 1993-03-03 |
| K921431 | POTTY PAGER | Ideas For Living | 1992-07-21 |
| K911279 | DRY TIME | Health Sense Intl., Inc. | 1991-09-04 |
| K903856 | WET-NO-MORE MONITOR | Travis Industries, Inc. | 1990-09-12 |
| K901907 | PROFESSIONAL MONITOR | Travis Industries, Inc. | 1990-09-12 |
| K901906 | WET-NO-MORE MONITOR | Travis Industries, Inc. | 1990-07-11 |
| K895852 | BUZZY BEAR ENURESIS ALARM | Med-Design, Inc. | 1990-02-12 |
| K895251 | BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) | C.R. Bard, Inc. | 1989-11-13 |
| K895346 | DR. DRY | Intellitech | 1989-10-24 |
| K885345 | HEALTHSHIELD | Jonas, Inc. | 1989-05-24 |
| K882555 | ANOTRON(R) INCONTINENCE CONTROL SYSTEM | Biosonics, Inc. | 1988-08-30 |
| K872522 | BED ALERT | Nite Train-R Enterprises, Inc. | 1988-01-19 |
| K871787 | ENURESIS ALARM | Dilorenzo Engineering Co. | 1987-08-10 |
| K864448 | THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM) | Biosonics, Inc. | 1987-02-06 |
| K862683 | BIOSOICS SPHINCTER TRAINING SYSTEM | Biosonics, Inc. | 1986-11-12 |
| K862757 | STARCHILD SLEEPDRY | Starchild, Inc. | 1986-10-29 |
| K854539 | UROSTAT | Urologics, Inc. | 1986-02-04 |
| K850538 | BED SENTRY, MODEL 50U | Metatech Corp. | 1985-04-03 |
| K844636 | SENTRY SIGNAL ENURESIS ALARM SYSTEM | Conklin Technology, Inc. | 1985-04-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10193489082739 | FITRIGHT | MEDLINE INDUSTRIES, INC. | 2026-03-05 |
| 00193489036414 | FITRIGHT | MEDLINE INDUSTRIES, INC. | 2026-03-05 |
| 20193489082736 | FITRIGHT | MEDLINE INDUSTRIES, INC. | 2026-03-05 |
| 10193489036411 | FITRIGHT | MEDLINE INDUSTRIES, INC. | 2026-03-05 |
| 00619013000183 | DRI Sleeper eclipse plus | ANZACARE LIMITED | 2026-02-16 |
| 00619013000039 | DRI Sleeper eclipse | ANZACARE LIMITED | 2026-02-16 |
| 00619013000015 | DRI Sleeper excel | ANZACARE LIMITED | 2026-02-16 |
| 00854950002702 | Chummie | Theos Medical Systems, Inc. | 2026-01-01 |
| 00854950002696 | Chummie | Theos Medical Systems, Inc. | 2026-01-01 |
| 00854950002689 | Chummie | Theos Medical Systems, Inc. | 2026-01-01 |
| 00854950002719 | Chummie | Theos Medical Systems, Inc. | 2026-01-01 |
| 00856455007428 | Wicked Smart | Wicked Sheets, LLC | 2025-11-19 |
| 00854950002184 | Chummie | Theos Medical Systems, Inc. | 2024-01-04 |
| 00854950002023 | Chummie | Theos Medical Systems, Inc. | 2024-01-04 |
| 00854950002030 | Chummie | Theos Medical Systems, Inc. | 2024-01-04 |
| 00854950002047 | Chummie | Theos Medical Systems, Inc. | 2024-01-04 |
| 00854950002078 | Chummie | Theos Medical Systems, Inc. | 2024-01-04 |
| 00854950002085 | Chummie | Theos Medical Systems, Inc. | 2024-01-04 |
| 00854950002153 | Chummie | Theos Medical Systems, Inc. | 2024-01-04 |
| 00854950002177 | Chummie | Theos Medical Systems, Inc. | 2024-01-04 |
| 00768702912891 | TENA | Essity Hygiene and Health AB | 2021-08-27 |
| 00768702912884 | TENA | Essity Hygiene and Health AB | 2021-08-27 |
| 00768702912877 | TENA | Essity Hygiene and Health AB | 2021-08-27 |
| 00768702912839 | TENA | Essity Hygiene and Health AB | 2020-09-01 |
| 00768702912815 | TENA | Essity Hygiene and Health AB | 2020-09-01 |
| 00768702600149 | TENA | Essity Hygiene and Health AB | 2016-09-16 |
| 00768702600132 | TENA | Essity Hygiene and Health AB | 2016-09-16 |
| 09342124000414 | SIM pants XXL | SIMAVITA (AUST) PTY LTD | 2016-06-03 |
| 09342124000407 | SIM pants XL | SIMAVITA (AUST) PTY LTD | 2016-06-03 |
| 09342124000179 | SIM pants Regular | SIMAVITA (AUST) PTY LTD | 2016-06-03 |