FDA Product Code
FDA Product Code KPN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.2040
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130951 | SIM | Simavita Pty Limited | 2013-08-22 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K971855 | POTTY PAL AND FOREVER-DRY | Digital Applications, Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K962770 | UROSURGE ACUTRAINER | Princeton Regulatory Assoc. | 1996-08-01 | Traditional | PDF ↗ |
| K962416 | DRYTIME FOR BLADDER CONTROL SILENT | Bio-Systems Research | 1996-07-22 | Traditional | PDF ↗ |
| K955338 | DRYTIME FOR POTTY TRAINING | Health Sense Intl., Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K943558 | PRO'TECT | Health Sense Intl., Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K943559 | REMOTE A'LERT | Health Sense Intl., Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K942057 | FISHER-PRICE DRY NIGHT MONITOR | Fisher Price | 1994-07-28 | Traditional | PDF ↗ |
| K935915 | WET SENSE | Edson Corp. | 1994-05-13 | Traditional | PDF ↗ |
| K934369 | DRI SLEEPER | Laborie Medical Technologies, Ltd. | 1993-11-24 | Traditional | PDF ↗ |
| K930005 | DRITRAINER | Laborie Medical Technologies, Ltd. | 1993-03-03 | Traditional | PDF ↗ |
| K921431 | POTTY PAGER | Ideas For Living | 1992-07-21 | Traditional | PDF ↗ |
| K911279 | DRY TIME | Health Sense Intl., Inc. | 1991-09-04 | Traditional | PDF ↗ |
| K901907 | PROFESSIONAL MONITOR | Travis Industries, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903856 | WET-NO-MORE MONITOR | Travis Industries, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K901906 | WET-NO-MORE MONITOR | Travis Industries, Inc. | 1990-07-11 | Traditional | PDF ↗ |
| K895852 | BUZZY BEAR ENURESIS ALARM | Med-Design, Inc. | 1990-02-12 | Traditional | PDF ↗ |
| K895251 | BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) | C.R. Bard, Inc. | 1989-11-13 | Traditional | PDF ↗ |
| K895346 | DR. DRY | Intellitech | 1989-10-24 | Traditional | PDF ↗ |
| K885345 | HEALTHSHIELD | Jonas, Inc. | 1989-05-24 | Traditional | PDF ↗ |
| K882555 | ANOTRON(R) INCONTINENCE CONTROL SYSTEM | Biosonics, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K872522 | BED ALERT | Nite Train-R Enterprises, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K871787 | ENURESIS ALARM | Dilorenzo Engineering Co. | 1987-08-10 | Traditional | PDF ↗ |
| K864448 | THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM) | Biosonics, Inc. | 1987-02-06 | Traditional | PDF ↗ |
| K862683 | BIOSOICS SPHINCTER TRAINING SYSTEM | Biosonics, Inc. | 1986-11-12 | Traditional | PDF ↗ |
| K862757 | STARCHILD SLEEPDRY | Starchild, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K854539 | UROSTAT | Urologics, Inc. | 1986-02-04 | Traditional | PDF ↗ |
| K844636 | SENTRY SIGNAL ENURESIS ALARM SYSTEM | Conklin Technology, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K850538 | BED SENTRY, MODEL 50U | Metatech Corp. | 1985-04-03 | Traditional | PDF ↗ |
| K844866 | NYTONE ENURETIC ALARM BEDWETTING DEVICE | Nytone Medical | 1985-04-03 | Traditional | PDF ↗ |
| K842547 | WET-STOP | Palco Laboratories, Inc. | 1984-10-19 | Traditional | PDF ↗ |
| K834311 | NIGHT TRAINER | Maddak, Inc. | 1984-03-30 | Traditional | PDF ↗ |
| K823276 | BED GUARD | T. S. Enterprises, Inc. | 1982-11-24 | Traditional | PDF ↗ |
| K821546 | MONITORING DEVICE ENURESIS ALARM & ACC. | Wetbell, Inc. | 1982-06-09 | Traditional | PDF ↗ |
| K782093 | DETECTOR PAD | Halperin Institute, Ltd. The | 1979-02-21 | Traditional | PDF ↗ |
| K780660 | NITE TRAIN'R | Nite Train-R Enterprises, Inc. | 1978-07-28 | Traditional | PDF ↗ |
Product code KPN · Class II · Gastroenterology, Urology. Data: openFDA.