Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart C — Monitoring Devices](/submissions/GU/subpart-c%E2%80%94monitoring-devices) → [21 CFR 876.2040](/submissions/GU/subpart-c%E2%80%94monitoring-devices/876.2040) → KPN — Alarm, Conditioned Response Enuresis # KPN · Alarm, Conditioned Response Enuresis _Gastroenterology, Urology · 21 CFR 876.2040 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN ## Overview - **Product Code:** KPN - **Device Name:** Alarm, Conditioned Response Enuresis - **Regulation:** [21 CFR 876.2040](/submissions/GU/subpart-c%E2%80%94monitoring-devices/876.2040) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## Identification An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9. ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K130951](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K130951.md) | SIM | Simavita Pty Limited | Aug 22, 2013 | SESE | | [K971442](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K971442.md) | 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 | SESE | | [K971855](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K971855.md) | POTTY PAL AND FOREVER-DRY | Digital Applications, Inc. | Aug 18, 1997 | SESE | | [K962770](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K962770.md) | UROSURGE ACUTRAINER | Princeton Regulatory Assoc. | Aug 1, 1996 | SESE | | [K962416](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K962416.md) | DRYTIME FOR BLADDER CONTROL SILENT | Bio-Systems Research | Jul 22, 1996 | SESE | | [K955338](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K955338.md) | DRYTIME FOR POTTY TRAINING | Health Sense Intl., Inc. | Mar 12, 1996 | SESE | | [K943559](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K943559.md) | REMOTE A'LERT | Health Sense Intl., Inc. | May 24, 1995 | SESE | | [K943558](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K943558.md) | PRO'TECT | Health Sense Intl., Inc. | May 24, 1995 | SESE | | [K942057](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K942057.md) | FISHER-PRICE DRY NIGHT MONITOR | Fisher Price | Jul 28, 1994 | SESE | | [K935915](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K935915.md) | WET SENSE | Edson Corp. | May 13, 1994 | SESE | | [K934369](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K934369.md) | DRI SLEEPER | Laborie Medical Technologies, Ltd. | Nov 24, 1993 | SESE | | [K930005](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K930005.md) | DRITRAINER | Laborie Medical Technologies, Ltd. | Mar 3, 1993 | SESE | | [K921431](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K921431.md) | POTTY PAGER | Ideas For Living | Jul 21, 1992 | SESE | | [K911279](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K911279.md) | DRY TIME | Health Sense Intl., Inc. | Sep 4, 1991 | SESE | | [K903856](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K903856.md) | WET-NO-MORE MONITOR | Travis Industries, Inc. | Sep 12, 1990 | SESE | | [K901907](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K901907.md) | PROFESSIONAL MONITOR | Travis Industries, Inc. | Sep 12, 1990 | SESE | | [K901906](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K901906.md) | WET-NO-MORE MONITOR | Travis Industries, Inc. | Jul 11, 1990 | SESE | | [K895852](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K895852.md) | BUZZY BEAR ENURESIS ALARM | Med-Design, Inc. | Feb 12, 1990 | SESE | | [K895251](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K895251.md) | BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) | C.R. Bard, Inc. | Nov 13, 1989 | SESE | | [K895346](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN/K895346.md) | DR. DRY | Intellitech | Oct 24, 1989 | SESE | ## Top Applicants - Health Sense Intl., Inc. — 4 clearances - Biosonics, Inc. — 3 clearances - Travis Industries, Inc. — 3 clearances - Laborie Medical Technologies, Ltd. — 2 clearances - Nite Train-R Enterprises, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN](https://fda.innolitics.com/submissions/GU/subpart-c%E2%80%94monitoring-devices/KPN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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