Enteral Feeding Bottle

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

510(k) Number

K841945 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Tracheostomy Care Kit Open recall

  Class II

  FDA 510(k) K761190 Active Cleared 16 Dec 1976

• 3.5 & 5.5 Oz. Sodium Chloride Solution

  Class II

  FDA 510(k) K820460 Active Cleared 8 Mar 1982

• 9 French 42LONG Polyurethane Graduated Enteric Fe

  Class II

  FDA 510(k) K843975 Active Cleared 20 Nov 1984

• Dispos. Enteric Feeding Tubes W/Safe-T

  Class II

  FDA 510(k) K833687 Active Cleared 2 Mar 1984

• Enteral Nutrition Pump

  Class II

  FDA 510(k) K841630 Active Cleared 7 Jun 1984

• Silicone Sump Drain 20 & 40 French

  Class I

  FDA 510(k) K840324 Active Cleared 25 Apr 1984

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• What is the enteral feeding bottle used for?

  The enteral feeding bottle is used to hold and deliver liquid nutrition or medication directly into the gastrointestinal tract through a feeding tube, supporting enteral nutrition in clinical or home care environments.

• Is the enteral feeding bottle sterile or non-sterile when supplied?

  The device is supplied non-sterile, as stated in the specifications, and is intended for single use only, meaning it should not be reprocessed or reused after initial application.

• What regulatory pathway was used for the enteral feeding bottle's clearance?

  The enteral feeding bottle received FDA 510(k) clearance under the traditional pathway, with clearance number K841945 granted on July 26, 1984, based on a determination of substantial equivalence.