Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes

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

510(k) Number

K181787 ↗

FDA Product Code

PIF

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Enteral Feeding Spike Adapter

  Class II

  FDA 510(k) K072652 Active Cleared 18 Jan 2008

• Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port

  Class II

  FDA 510(k) K150010 Active Cleared 2 Apr 2015

• Cedic Enteral Distal End Enfit Transition Connector

  Class II

  FDA 510(k) K140581 Active Cleared 17 Oct 2014

• Cedic Enteral ENFit Transition Connectors

  Class II

  FDA 510(k) K162254 Active Cleared 4 May 2017

• F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer Lock

  Class II

  FDA 510(k) K042129 Active Cleared 27 Jan 2005

• ENConnect 40 mm Screw Cap to ENPlus Adapter

  Class II

  FDA 510(k) K190327 Active Cleared 9 Apr 2019

• What are Cediflo Enteral Feeding Tubes used for?

  These tubes are designed for nasoenteric administration of enteral nutrition, fluids, and medications into the stomach or small intestine. Their specialized connectors ensure secure and reliable delivery, reducing patient discomfort and minimizing complications during prolonged use. They are ideal for clinical settings like hospitals, nursing homes, and home healthcare.

• Are Cediflo Enteral Feeding Tubes single-use or reusable?

  The Cediflo Enteral Feeding Tubes are explicitly labeled as single-use medical devices. This classification ensures patient safety by preventing cross-contamination and maintaining sterility for each procedure, which is critical for enteral feeding applications.

• What sizes and models are available for Cediflo Enteral Feeding Tubes?

  Multiple sizes and reference codes are available to accommodate various patient needs. The tubes are categorized under FDA product code PIF, with numerous FEI numbers listed in the regulatory submission (e.g., 3010017366, 3005580113, etc.). These variations ensure compatibility with different procedural requirements and patient anatomies.

• How should Cediflo Enteral Feeding Tubes be stored?

  While the provided data does not specify storage conditions explicitly, single-use medical devices like these typically require protection from contamination, extreme temperatures, and direct light. They should be stored in their original packaging until use, following manufacturer guidelines to preserve sterility and functionality.

• What regulatory approvals do Cediflo Enteral Feeding Tubes hold?

  The Cediflo Enteral Feeding Tubes received FDA 510(k) clearance (K181787) as substantially equivalent to predicate devices. This clearance was reviewed by the Gastroenterology and Urology (GU) advisory committee, confirming their compliance with FDA standards for gastrointestinal tubes with enteral-specific connectors.