Leider Feeding Tube W/Hydromer Lubr

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

510(k) Number

K833293 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Entron Enteral Feeding Bag

  Class II

  FDA 510(k) K850134 Active Cleared 14 Feb 1985

• Peewee Replacement Gastrostomy Tube

  Class II

  FDA 510(k) K903662 Active Cleared 12 Dec 1990

• Islami Gastrointestinal Tube

  Class II

  FDA 510(k) K834268 Active Cleared 4 Feb 1984

• Pedi-Tube Pediatric Feeding Tube

  Class II

  FDA 510(k) K822875 Active Cleared 13 Oct 1982

• Enteral Feeding Tube

  Class II

  FDA 510(k) K051480 Active Cleared 12 Oct 2005

• Ambi-24 Ph/Pressure Monitor

  Class I

  FDA 510(k) K854514 Active Cleared 24 Feb 1986

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• What is the primary purpose of the Leider Feeding Tube with Hydromer Lubrication and how does the built-in lubrication help during use?

  The Leider Feeding Tube with Hydromer Lubrication is designed specifically for enteral nutrition delivery, meaning it provides a direct route for feeding formulas into the gastrointestinal tract. The built-in Hydromer lubrication is included to ease insertion into the patient’s body and reduce discomfort during placement, which can be particularly helpful in clinical settings where patient tolerance is a concern.

• Is this feeding tube intended for single-use or can it be reused after cleaning?

  The Leider Feeding Tube with Hydromer Lubrication is explicitly labeled as a single-use medical product. This designation means it is intended for one-time clinical use only, and reuse is not recommended or supported by the manufacturer.

• What types of clinical settings or patient populations would this tube be most suitable for?

  This tube is designed for clinical settings where enteral nutrition is required, such as hospitals, long-term care facilities, or home healthcare environments. It would be suitable for patients who need long-term or temporary enteral feeding due to conditions like dysphagia, gastrointestinal disorders, or those who are unable to consume adequate nutrition orally.

• How is the Leider Feeding Tube with Hydromer Lubrication regulated, and what does the product code KNT indicate?

  The Leider Feeding Tube with Hydromer Lubrication is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K833293. The product code KNT categorizes it under the classification Tubes, Gastrointestinal (and Accessories), which is part of the FDA’s medical device classification system. This code helps identify its intended use and regulatory pathway.