Urinary Collection Container/Leg Bag

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

510(k) Number

K821171 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• External Female Urinary Incontinence

  Class II

  FDA 510(k) K821172 Active Cleared 10 May 1982

• Urine Collection Containers, #3600 & 3610

  Class II

  FDA 510(k) K801786 Active Cleared 30 Sep 1980

• Show'rbag

  Class I

  FDA 510(k) K822059 Active Cleared 22 Jul 1982

• Urinary Catheter Care Trays #3700&3710

  Class II

  FDA 510(k) K801787 Active Cleared 21 Oct 1980

• Softic 49

  Class II

  FDA 510(k) K821230 Active Cleared 28 May 1982

• Large Volume Enema Container Disposable

  Class I

  FDA 510(k) K800959 Active Cleared 14 May 1980

See all devices from The Healthcare Group Laboratories, Inc. →

• What is the primary purpose of this urinary collection container/leg bag and where is it typically used?

  This device is designed specifically for collecting and containing urine from patients who have indwelling urinary catheters. It replaces traditional bedpan or bedside collection methods to provide continuous drainage while maintaining hygiene. It is intended for use in clinical settings such as hospitals, nursing homes, or home healthcare environments, where patients require long-term or continuous urine collection.

• Is this urinary collection container/leg bag meant for single-use or can it be reused?

  The urinary collection container/leg bag is explicitly labeled as a single-use device. This ensures sterility and reduces the risk of contamination or infection, which is critical for maintaining patient safety during urine collection.

• How is this device typically worn or positioned for use?

  The bag is designed to be worn around the leg or securely attached to a bed frame. This positioning allows for convenient and continuous urine collection without disrupting the patient’s mobility or comfort.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

  This device received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets the necessary safety and performance standards for its intended use in clinical settings.

• Are there different sizes or models available for this urinary collection container/leg bag?

  While the provided data does not specify exact sizes or model variations, the device is categorized under product code KNX for collectors, urine (and accessories) for indwelling catheters. Typically, such devices may offer variations in capacity or attachment styles to accommodate different patient needs, though the exact models would need to be confirmed with the manufacturer.