Subpart C—Monitoring Devices
FDA submissions for Subpart C—Monitoring Devices in the Gastroenterology, Urology (GU) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 876.2040–876.2100
CFR Part: 876
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KPN | Alarm, Conditioned Response Enuresis | 876.2040 | 2 | 37 |
| OQT | Prostate Lesion, Documentation, System | 876.2050 | 2 | 1 |
| QEF | Pressure Ulcer Management Tool | 876.2100 | 1 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| DEN170021 | SEM Scanner (Model 200) | Bruin Biometrics, LLC | Dec 20, 2018 |
| K130951 | SIM | Simavita Pty Limited | Aug 22, 2013 |
| DEN100016 | PROSTATE MECHANICAL IMAGER | Artann Laboratories, Inc. | Apr 27, 2012 |
| 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. | Jan 8, 1998 |
| K971855 | POTTY PAL AND FOREVER-DRY | Digital Applications, Inc. | Aug 18, 1997 |
| K962770 | UROSURGE ACUTRAINER | Princeton Regulatory Assoc. | Aug 1, 1996 |
| K962416 | DRYTIME FOR BLADDER CONTROL SILENT | Bio-Systems Research | Jul 22, 1996 |
| K955338 | DRYTIME FOR POTTY TRAINING | Health Sense Intl., Inc. | Mar 12, 1996 |
| K943559 | REMOTE A'LERT | Health Sense Intl., Inc. | May 24, 1995 |
| K943558 | PRO'TECT | Health Sense Intl., Inc. | May 24, 1995 |
| K942057 | FISHER-PRICE DRY NIGHT MONITOR | Fisher Price | Jul 28, 1994 |
| K935915 | WET SENSE | Edson Corp. | May 13, 1994 |
| K934369 | DRI SLEEPER | Laborie Medical Technologies, Ltd. | Nov 24, 1993 |
| K930005 | DRITRAINER | Laborie Medical Technologies, Ltd. | Mar 3, 1993 |
| K921431 | POTTY PAGER | Ideas For Living | Jul 21, 1992 |
| K911279 | DRY TIME | Health Sense Intl., Inc. | Sep 4, 1991 |
| K903856 | WET-NO-MORE MONITOR | Travis Industries, Inc. | Sep 12, 1990 |
| K901907 | PROFESSIONAL MONITOR | Travis Industries, Inc. | Sep 12, 1990 |
| K901906 | WET-NO-MORE MONITOR | Travis Industries, Inc. | Jul 11, 1990 |
| K895852 | BUZZY BEAR ENURESIS ALARM | Med-Design, Inc. | Feb 12, 1990 |
| K895251 | BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) | C.R. Bard, Inc. | Nov 13, 1989 |
| K895346 | DR. DRY | Intellitech | Oct 24, 1989 |
| K885345 | HEALTHSHIELD | Jonas, Inc. | May 24, 1989 |
| K882555 | ANOTRON(R) INCONTINENCE CONTROL SYSTEM | Biosonics, Inc. | Aug 30, 1988 |
| K872522 | BED ALERT | Nite Train-R Enterprises, Inc. | Jan 19, 1988 |
| K871787 | ENURESIS ALARM | Dilorenzo Engineering Co. | Aug 10, 1987 |
| K864448 | THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM) | Biosonics, Inc. | Feb 6, 1987 |
| K862683 | BIOSOICS SPHINCTER TRAINING SYSTEM | Biosonics, Inc. | Nov 12, 1986 |
| K862757 | STARCHILD SLEEPDRY | Starchild, Inc. | Oct 29, 1986 |
| K854539 | UROSTAT | Urologics, Inc. | Feb 4, 1986 |
| K850538 | BED SENTRY, MODEL 50U | Metatech Corp. | Apr 3, 1985 |
| K844866 | NYTONE ENURETIC ALARM BEDWETTING DEVICE | Nytone Medical | Apr 3, 1985 |
| K844636 | SENTRY SIGNAL ENURESIS ALARM SYSTEM | Conklin Technology, Inc. | Apr 3, 1985 |
| K842547 | WET-STOP | Palco Laboratories, Inc. | Oct 19, 1984 |
| K834311 | NIGHT TRAINER | Maddak, Inc. | Mar 30, 1984 |
| K823276 | BED GUARD | T. S. Enterprises, Inc. | Nov 24, 1982 |
| K821546 | MONITORING DEVICE ENURESIS ALARM & ACC. | Wetbell, Inc. | Jun 9, 1982 |
| K782093 | DETECTOR PAD | Halperin Institute, Ltd. The | Feb 21, 1979 |
| K780660 | NITE TRAIN'R | Nite Train-R Enterprises, Inc. | Jul 28, 1978 |
