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Bed Alert

by Nite Train-R Enterprises, Inc.

510(k) K872522

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872522 Date19 Jan 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Bed Alert is a Conditioned Response Enuresis Alarm designed to detect the onset of urination and provide an auditory alert. It functions as a non-invasive device intended to train children to recognize and control bedwetting episodes by responding to moisture contact on a sensor pad.

This device is supplied as a reusable alarm system with a moisture-sensitive pad placed under the user. It is not sterile and is intended for home use, requiring no regulatory restrictions beyond its FDA 510(k) clearance (K872522) under product code KPN. The device is classified as Class II and adheres to regulation 876.2040, with no MRI safety considerations specified.

Other devices from Nite Train-R Enterprises, Inc.

  • Nite Train'r

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Bed Alert designed to help children with?

    The Bed Alert is a Conditioned Response Enuresis Alarm designed specifically to help children with bedwetting. It works by detecting the onset of urination through a moisture-sensitive pad placed under the user. When moisture is detected, the device emits an auditory alert, helping children learn to recognize and control bedwetting episodes over time.

  • Is the Bed Alert reusable or single-use?

    The Bed Alert is supplied as a reusable alarm system. This means it is intended for long-term use in a home setting, allowing families to train multiple children or use it consistently over time without needing to replace the entire device.

  • Does the Bed Alert require any special handling or sterility?

    The Bed Alert is not sterile and is designed for home use. Since it is reusable and intended for non-invasive contact with the user, there are no regulatory restrictions beyond its FDA 510(k) clearance. Standard hygiene practices, such as cleaning the moisture-sensitive pad between uses, are recommended.

  • What regulatory approval does the Bed Alert hold?

    The Bed Alert holds FDA 510(k) clearance under the product code KPN, classified as a Class II device under regulation 876.2040. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed device and meets applicable safety and performance standards.

  • Are there any safety concerns related to the Bed Alert, such as MRI compatibility?

    The Bed Alert does not have any specified MRI safety considerations. Since it is a non-invasive, non-electronic (or minimally electronic) device intended for home use, there are no known restrictions related to MRI environments or electromagnetic interference.