Kangaroo Enteral Feeding Extension Set for Syringe Pumps

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

510(k) Number

K973409 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Kangaroo Enteral Feeding Extension Set designed to do in clinical settings?

  The Kangaroo Enteral Feeding Extension Set connects syringe pumps to enteral feeding tubes, allowing for the precise and controlled administration of feeding formulas through a non-intravenous connector. It bridges the syringe pump and the feeding tube to ensure accurate delivery of nutrients without intravenous access.

• Is this device meant for repeated use or is it intended for single-use only?

  This device is explicitly designed for single-use in clinical environments like hospitals and home care. It is supplied sterile and does not require additional preparation beyond standard aseptic handling, making it ideal for one-time use per patient to maintain safety and hygiene.

• How should the Kangaroo Enteral Feeding Extension Set be stored before use?

  Since the device is supplied sterile, it should be stored in its original packaging until ready for use. The packaging is likely sealed to preserve sterility, so it’s important to avoid opening or handling it until immediate clinical use. Always follow manufacturer guidelines for storage conditions to ensure the device remains uncontaminated.

• What regulatory pathway was followed for FDA clearance of this device?

  The Kangaroo Enteral Feeding Extension Set received FDA clearance through a 510(k) submission under the Traditional Review pathway. It was determined to be substantially equivalent to a legally marketed predicate device and was reviewed by the Gastroenterology, Urology (GU) Advisory Committee. The clearance number is K973409, filed in 1997.