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Hospira Enteral Feeding Set, Model 20640

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061432

by Hospira, Inc.

Identifiers

510(k) Number
K061432 FDA 510(k)
FDA Product Code
KNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hospira Enteral Feeding Set, Model 20640 is a set of components that delivers liquid nutrition formulas to enteral feeding tubes. It includes non‑DEHP plasticized polyvinyl tubing, non‑PVC feeding bags, fluid shut‑off devices, sight chambers, and an infusion cassette, allowing delivery by gravity or pump in clinical settings.

The set is cleared under FDA 510(k) (K061432) with a traditional clearance type and a decision of Substantially Equivalent (SESE) dated 2006‑09‑11. It is identified by product code KNT and was submitted by Hospira, Inc. in Lake Forest, Illinois.

Frequently asked questions

What is the Hospira Enteral Feeding Set Model 20640 used for?

The Hospira Enteral Feeding Set Model 20640 is used to deliver liquid nutrition formulas to enteral feeding tubes in clinical settings, supporting both gravity and pump-assisted administration.

What components are included in the Hospira Enteral Feeding Set Model 20640?

The set includes non-DEHP plasticized polyvinyl tubing, non-PVC feeding bags, fluid shut-off devices, sight chambers, and an infusion cassette, which together enable safe and controlled delivery of enteral nutrition.

Is the Hospira Enteral Feeding Set Model 20640 intended for single-use or reuse?

Based on its design as a disposable enteral feeding set with integrated fluid shut-off and sight chambers, the Hospira Enteral Feeding Set Model 20640 is intended for single-use only to prevent contamination and ensure patient safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HOSPIRA ENTERAL FEEDING SET, MODEL 20640 (K061432) — FDA 510 (k ..., PDF K061432 - Hospira Enteral Feeding Set, Model 20640, HOSPIRA ENTERAL FEEDING SET, MODEL 20640 510(k) K061432 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hospira, Inc.

Sources (1)

  • FDA 510(k) K061432 24 fields · synced Oct 1, 2026