Disposable Urinary Legbag W/Strap

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

510(k) Number

K821168 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• The Mmg 5 in 1 Connector

  Class I

  FDA 510(k) K863912 Active Cleared 27 Oct 1986

• Mmg Urinary Drainage Tubing

  Class II

  FDA 510(k) K811469 Active Cleared 12 Jun 1981

• Mmg Uro-Self Catheter

  Class II

  FDA 510(k) K871999 Active Cleared 25 Aug 1987

• O'Neil Urinary Catheter Introducer

  Class II

  FDA 510(k) K884819 Active Cleared 17 Feb 1989

• MMG Disposable Urinary Leg Bag

  Class II

  FDA 510(k) K800694 Active Cleared 30 May 1980

• Mmg/O'neil Urinary Catheterization System Kit

  Class II

  FDA 510(k) K910022 Active Cleared 2 Apr 1991

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• What is the primary purpose of this urinary legbag, and who would benefit from using it?

  This disposable urinary legbag is designed to collect and temporarily hold urine for patients who cannot walk or need continuous drainage, such as those with urinary incontinence or catheter-dependent conditions. It attaches securely to the lower leg via adjustable straps, allowing mobility while maintaining drainage. Ideal users include in-patient or home-care patients requiring catheterization.

• Is this device single-use or reusable, and how should it be stored before use?

  The device is explicitly labeled as single-use only, meaning it should not be reused after one patient application. It is supplied sterile, so storage instructions emphasize keeping it in its original, sealed packaging until ready for use. Avoid exposure to moisture, extreme temperatures, or contamination to preserve sterility.

• What features does the legbag include for secure attachment and compatibility with catheters?

  The legbag includes adjustable straps for secure positioning on the lower leg, ensuring it stays in place while allowing mobility. It also features a universal-tiered connector, making it compatible with most indwelling catheters. The drain valve provides controlled urine release, and its design prioritizes patient comfort and ease of use.

• How do I know this device meets regulatory standards, and what classification does it fall under?

  This device was authorized through the FDA 510(k) clearance process (K821168) and is classified under Class II regulatory standards (product code: 876.5250). It adheres to OpenFDA’s nomenclature for Collector, Urine (and Accessories) for Indwelling Catheter, ensuring it meets established safety and performance criteria for urinary collection devices.

• Can this legbag be used in environments where MRI scans are performed, or does it have any MRI-related restrictions?

  The device data does not specify any MRI safety features or restrictions, meaning it should not be assumed safe for use in MRI environments. Clinicians should verify compatibility with their specific MRI equipment and protocols before use, as non-MRI-safe materials could pose risks during scans.