Enteral Nutrition Warmer

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

510(k) Number

K122449 ↗

FDA Product Code

LGZ

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Spring Loaded Syringe

  Class II

  FDA 510(k) K931095 Active Cleared 16 Sep 1993

• Syringe Tip Adaptor

  Class II

  FDA 510(k) K894217 Active Cleared 12 Sep 1989

• Intopo

  Class II

  FDA 510(k) K894206 Active Cleared 27 Oct 1989

• Luer Lock Transfer Pin

  Class II

  FDA 510(k) K901063 Active Cleared 6 Jul 1990

• Blood Sampling Set

  Class II

  FDA 510(k) K103165 Active Cleared 10 Nov 2010

• Acacia Piston Syringe

  Class II

  FDA 510(k) K092986 Active Cleared 27 Oct 2009

See all devices from Acacia, Inc. →

• What is the primary purpose of the Enteral Nutrition Warmer from Acacia, Inc. and where is it typically used?

  The Enteral Nutrition Warmer is designed to provide controlled external heat to maintain the temperature of enteral feeding formulas or fluids during administration. This ensures safe and effective delivery to patients requiring nutritional support. It is specifically intended for use in hospital settings, where precise temperature control is critical for patient care.

• Is the Enteral Nutrition Warmer available in single-use or reusable versions, and how should it be handled?

  The Enteral Nutrition Warmer can be supplied as either single-use or reusable, depending on the specific model or manufacturer’s specifications. Handling follows standard aseptic practices for medical devices, as outlined in the device’s regulatory documentation, to maintain safety and sterility.

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

  The Enteral Nutrition Warmer received FDA clearance through a 510(k) submission (K122449), classified as substantially equivalent under 21 CFR 880.5725. This means it was determined to be as safe and effective as a legally marketed device already on the market, allowing it to be used in clinical settings as intended for controlled heating of enteral feeding solutions.

• Does the Enteral Nutrition Warmer have any special compatibility considerations, such as magnetic interference or MRI safety?

  The device is explicitly noted as non-magnetic, making it compatible with standard hospital environments. However, its MRI safety is not specified, so caution should be exercised when placing it near MRI machines unless verified by the manufacturer.

• What types of enteral feeding administration sets is this warmer compatible with, and how many models or variations exist?

  The Enteral Nutrition Warmer is designed for use with enteral feeding administration sets commonly used in hospital nutrition support. While the exact specifications for compatibility (e.g., tubing size, connector types) would depend on the model, the device is listed under multiple product codes (e.g., LGZ), indicating it may accommodate various configurations. The manufacturer’s documentation should specify which sets are compatible.