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Drytime for Potty Training

by Health Sense Intl., Inc.

510(k) K955338

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 NumberK955338 Date12 Mar 1996ClearedStatusActive

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  • Withdrawn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, 18 Sep 2026

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

The Drytime for Potty Training is a conditioned response enuresis alarm, a Class II medical device designed to treat bedwetting in children. It operates by detecting a small amount of urine on a sensing pad and activating an audible alarm to prompt the user to respond, reinforcing bladder control through conditioned learning.

This device is supplied as a reusable system, including a sensing pad and alarm unit, and is intended for home use. It is not sterile and requires cleaning between uses. The device falls under FDA regulation under § 876.2040 and was granted 510(k) clearance (K955338) in 1996. No MRI safety information or additional regulatory markings are specified.

Other devices from Health Sense Intl., Inc.

  • Dry Time

    Class II

  • Pro'tect

    Class II

  • Remote a'lert

    Class II

Questions

AI-generated answers, 18 Sep 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 Drytime for Potty Training device used for and how does it work?

    The Drytime for Potty Training is a conditioned response enuresis alarm designed to help children learn bladder control by addressing bedwetting. It works by detecting even small amounts of urine on a reusable sensing pad placed under the child’s bedding. When urine is detected, the device activates an audible alarm, prompting the child to wake up and respond, reinforcing proper bladder control through repeated conditioning.

  • Is the Drytime device meant for single-use or reusable, and how should it be maintained?

    The Drytime device is a reusable system, consisting of a sensing pad and alarm unit intended for home use. Since it is not sterile, it requires cleaning between uses to maintain hygiene and functionality. Regular maintenance ensures the device remains effective for long-term use.

  • What regulatory pathway was followed for the FDA clearance of the Drytime device?

    The Drytime for Potty Training received FDA clearance through a 510(k) premarket notification process, specifically under Traditional Review with a Substantially Equivalent (SESE) determination. The device falls under FDA regulation § 876.2040 and was cleared in 1996 (K955338). The review was conducted by the Gastroenterology and Urology (GU) Advisory Committee.

  • Are there different sizes or models available for the Drytime device?

    The provided data lists multiple registration numbers (e.g., 3014926187, 3003952845, etc.), which may correspond to different lot batches or configurations, but no explicit size or model variations are detailed in the description. If sizing is a concern, the manufacturer should be consulted for compatibility with the child’s bedding or specific use case.