Hill Nasogastric Tube

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K883319 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Zinetics AMC

  Class II

  FDA 510(k) K921682 Active Cleared 29 Dec 1994

• Zinetics Internal Reference Probe

  Class I

  FDA 510(k) K910694 Active Cleared 17 May 1991

• Zinetics(R) Emc

  Class II

  FDA 510(k) K884527 Active Cleared 28 Feb 1989

• What clinical purposes is the Hill Nasogastric Tube designed for, and how does it function in patient care?

  The Hill Nasogastric Tube is a flexible catheter inserted through the nose to access the stomach, enabling feeding, decompression, or drainage of gastric contents. It is specifically intended for procedures requiring gastric access via the nasal passage, such as managing bowel obstruction or aiding recovery after surgery. The tube creates a pathway for administering liquids or removing stomach contents, supporting patient care in critical or postoperative scenarios.

• Is the Hill Nasogastric Tube intended for single-use or can it be reused, and what does that mean for clinical workflows?

  The Hill Nasogastric Tube is explicitly labeled as a single-use medical device. This means each tube is designed for one-time use in a single patient, after which it must be discarded. Clinically, this ensures patient safety by reducing infection risks and simplifies workflows by eliminating the need for cleaning, sterilization, or reprocessing between uses.

• What regulatory pathway did the Hill Nasogastric Tube follow to gain market authorization, and what does that imply about its safety and equivalence?

  The Hill Nasogastric Tube received FDA clearance through a 510(k) submission (K883319) with a traditional review process, reviewed by the Gastroenterology and Urology Advisory Committee. The device was determined to be substantially equivalent (SESE) to a legally marketed predicate, meaning the FDA concluded it has the same intended use and technological characteristics as the predicate while meeting applicable safety and effectiveness requirements. This pathway ensures the device adheres to regulatory standards for safety and performance.

• Are there specific storage instructions provided for the Hill Nasogastric Tube, or should standard medical device practices be followed?

  The regulatory data does not specify exact storage conditions for the Hill Nasogastric Tube. However, it advises following standard medical device storage practices, which typically include protecting the device from contamination, extreme temperatures, and physical damage. This ensures the tube remains intact and ready for use when needed in clinical settings.

• What sizes or models are available for the Hill Nasogastric Tube, and how might that affect patient selection?

  While the exact dimensions or model variations (e.g., French sizes, length, or lumen configurations) are not detailed in the submission, the Hill Nasogastric Tube is supplied in standard sizes as referenced in its product specifications. Clinicians should consult the manufacturer’s labeling or technical documentation to select the appropriate size based on patient anatomy (e.g., age, nasal passage width) and clinical needs (e.g., feeding volume or drainage requirements). Proper sizing is critical to ensure comfort, functionality, and patient safety.