Enuresis Alarm (K871787)
by Dilorenzo Engineering Co. 510(k)
Active
510(k) K871787
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871787 | Date10 Aug 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- Enuresis Alarm
- 510(k) Number
- FDA Product Code
- KPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.2040
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Enuresis Alarm (K871787) is a Conditioned Response Enuresis Alarm, classified under FDA Product Code KPN. This device is designed to treat bedwetting by detecting small quantities of urine on a sensing pad and triggering an auditory or vibratory signal to alert the user, promoting conditioned bladder control through repeated awakening during urination events.
The Enuresis Alarm is supplied as a non-sterile, single-use or reusable device (depending on pad configuration) and is intended for home use. It operates via a moisture-sensitive pad connected to an alarm unit, with no MRI safety considerations specified. The device was cleared under FDA 510(k) (K871787) in 1987, falling under Class II regulatory classification (21 CFR 876.2040). No third-party reprocessing is indicated, and storage conditions are not detailed in the regulatory submission.
Questions
AI-generated answers, 1 Oct 2026
What is the Enuresis Alarm K871787 designed to treat?
The Enuresis Alarm K871787 is a Conditioned Response Enuresis Alarm intended to treat bedwetting (enuresis) in users. It works by detecting small amounts of urine on a moisture-sensitive pad, then activating an auditory or vibratory signal to wake the user. This repeated awakening during urination helps train the bladder to stay controlled, reducing nighttime accidents over time.
Is the Enuresis Alarm K871787 sterile, and how is it supplied?
The Enuresis Alarm K871787 is supplied as a non-sterile device. It is available in configurations that allow for either single-use or reusable pads, depending on the specific model. The alarm unit itself is reusable, while the sensing pad may need replacement after use, depending on the chosen setup.
Can the Enuresis Alarm K871787 be reused, or is it single-use?
The Enuresis Alarm K871787’s reusability depends on the pad configuration. The alarm unit itself is designed for repeated use, but the moisture-sensitive pad may be either single-use (disposable) or reusable (washable, if specified by the manufacturer). Check the included instructions for your specific pad type to determine proper usage and maintenance.
What storage conditions should be followed for the Enuresis Alarm K871787?
The regulatory submission for the Enuresis Alarm K871787 does not specify detailed storage conditions. However, as a general guideline for home-use medical devices, it should be stored in a cool, dry place, away from direct sunlight or extreme temperatures. If the pad is reusable, follow manufacturer instructions for cleaning and drying to maintain functionality.
Is third-party reprocessing allowed for the Enuresis Alarm K871787?
No, third-party reprocessing is not indicated for the Enuresis Alarm K871787. The device is intended for home use, and any reprocessing (e.g., cleaning or sterilization) should only be performed by the user or as instructed by the manufacturer. The alarm unit is designed for repeated use, but the pad’s reprocessing depends on whether it is single-use or reusable.