Curity Bedside Drainage Bag

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

510(k) Number

K813621 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Curity Venous Catheterization Kit

  Class II

  FDA 510(k) K861828 Active Cleared 10 Jul 1986

• Curity Fiberoptic Intubating Airway

  Class I

  FDA 510(k) K855137 Active Cleared 11 Mar 1986

• Curity Curad Bandages

  Class I

  FDA 510(k) K810126 Active Cleared 6 Feb 1981

• The Kendall Urinary Output Monitor

  Class I

  FDA 510(k) K852083 Active Cleared 20 Sep 1985

• Kendall Curity Irrigation Syringe

  Class II

  FDA 510(k) K892436 Active Cleared 14 Jul 1989

• Curity Continuous Epidural Anesthesia Tray

  Class II

  FDA 510(k) K871066 Active Cleared 15 May 1987

See all devices from The Kendal Co. →

• What is the primary purpose of the Curity Bedside Drainage Bag?

  This device is designed to function as a urine collector and accessory for patients using indwelling catheters. It provides a secure container for urine drainage with a total volume capacity of 2,000 mL.

• Does this drainage bag include features to prevent backflow?

  Yes, the device features an integrated anti-reflux chamber. This design element is included to help minimize the risk of spills and prevent urine from flowing back toward the catheter.

• How is the Curity Bedside Drainage Bag supplied?

  The product is supplied as a single unit per package, ensuring that each bag is ready for use as required by the clinician or patient.

• What is the regulatory status of this device?

  The Curity Bedside Drainage Bag is regulated under FDA 510(k) clearance K813621, which confirms its status as a device that has been reviewed and cleared for use.