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Urinary Drainage Bag (KNX)

by Snyder Laboratories, Inc.

510(k) K790253

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790253 Date10 Apr 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Urinary Drainage Bag
510(k) Number
FDA Product Code
KNX
Device Class
Class II
Regulation
21 CFR Part 876.5250
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

This device is a Collector, Urine, (And Accessories) For Indwelling Catheter, designed to collect and store urine drained from an indwelling urinary catheter. It is intended for continuous drainage of urine from patients with urinary retention or incontinence, ensuring proper hydration monitoring and patient comfort.

The Urinary Drainage Bag (KNX) is supplied as a single-use, non-sterile medical device, intended for use in clinical settings such as hospitals, nursing facilities, and home healthcare. It is regulated under FDA 510(k) clearance (K790253) and falls under the classification of Class II medical devices (regulation number 876.5250). The bag is available in a standard 2000 mL capacity, with graduated markings for precise urine output measurement. No MRI safety information is specified.

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