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Drytime for Bladder Control Silent

by Bio-Systems Research

510(k) K962416

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 NumberK962416 Date22 Jul 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  • Withdrawn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, 19 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 device is an alarm, conditioned response enuresis, designed to assist in the control of incontinence. It is intended for use by ambulatory adults as a daytime enuresis alarm.

It is supplied as a reusable device and has been cleared through the FDA 510(k) process under K962416. The device is classified as Class II and is authorized for use in the United States.

Other devices from Bio-Systems Research

Questions

AI-generated answers, 19 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 primary purpose of the DRYTIME FOR BLADDER CONTROL SILENT device, and who is it designed for?

    The DRYTIME FOR BLADDER CONTROL SILENT is an alarm designed as a conditioned response enuresis device to assist with daytime bladder control. It is specifically intended for use by ambulatory adults experiencing incontinence, helping them train their bladder through auditory feedback when leakage occurs.

  • Is the DRYTIME device reusable, and how does this affect its maintenance?

    Yes, the DRYTIME FOR BLADDER CONTROL SILENT is supplied as a reusable device, meaning it can be used repeatedly by multiple patients. This design reduces single-use waste but requires proper cleaning and maintenance per manufacturer guidelines to ensure hygiene and functionality over time.

  • What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

    The device was cleared through the FDA 510(k) process under reference number K962416, following a traditional review with a substantially equivalent determination. It is classified as a Class II medical device, indicating moderate regulatory oversight due to its intended use in managing incontinence.

  • Are there different sizes or models available for the DRYTIME device, and how would a clinician determine the appropriate fit?

    The provided data does not specify distinct sizes or models for the DRYTIME device, but it is designed as a conditioned response alarm system for daytime enuresis. Fit and usability depend on the user’s specific bladder control needs and the device’s adjustable settings (e.g., sensitivity levels). Clinicians should assess the patient’s incontinence type and consult the manufacturer’s instructions for optimal use.