Urinary Catheters

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

510(k) Number

K031409 ↗

FDA Product Code

GBM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Babyair

  Class II

  FDA 510(k) K060497 Active Cleared 11 Jul 2006

• Non-IV Adapter for Infant Ng Tube

  Class II

  FDA 510(k) K072756 Active Cleared 19 Dec 2007

• Infant Feeding Tubes

  Class II

  FDA 510(k) K020005 Active Cleared 16 Jul 2002

• Burlew Infant Hood

  Class I

  FDA 510(k) K962182 Active Cleared 15 Jul 1996

• Fenestrated Infusion Catheter

  Class II

  FDA 510(k) K024190 Active Cleared 17 Mar 2003

• Clearpath 24

  Class II

  FDA 510(k) K112318 Active Cleared 29 Jun 2012

See all devices from Promedic, Inc. →

• What is the intended use of this urinary catheter?

  This urinary catheter is a urethral catheter used for drainage of the urinary bladder, as stated in the device description, and is indicated for patients requiring bladder drainage in clinical settings.

• How is this device supplied and is it sterile?

  The device data does not specify sterility or supply format; however, as a urethral catheter cleared via FDA 510(k), it is typically supplied sterile for single-use to prevent infection, consistent with standard urethral catheter practices.

• What is the regulatory pathway and classification for this device?

  This device was cleared via the FDA 510(k) process under K031409 on June 17, 2003, as substantially equivalent to a legally marketed predicate, and is classified as a Class II device under regulation number 876.5130 with product code GBM.