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Dale Ace Connector (Access Controller for Enteral), Model H84104751

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K082241

by Dale Medical Products, Inc.

Identifiers

510(k) Number
K082241 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 Dale Ace Connector (Access Controller for Enteral), Model H84104751, is a medical device classified as an enteral feeding connector designed to facilitate secure and controlled access to enteral administration systems. It ensures proper connection between enteral tubes and feeding devices, reducing the risk of disconnections and contamination during enteral nutrition therapy.

This device is supplied as a single-use, non-sterile accessory intended for use in clinical settings such as hospitals and home healthcare environments. It is regulated under FDA 510K clearance and EU MDR, with a product code KNT under the Gastroenterology and Urology advisory committees. The connector is intended for enteral feeding applications and must be handled in accordance with standard infection control practices.

Frequently asked questions

What clinical environments is the Dale Ace Connector designed for use in, and how does it improve patient safety during enteral feeding?

The Dale Ace Connector is intended for use in clinical settings like hospitals and home healthcare environments where enteral feeding is administered. It improves patient safety by ensuring a secure and controlled connection between enteral tubes and feeding devices, which helps minimize the risk of accidental disconnections and contamination during enteral nutrition therapy.

Is the Dale Ace Connector sterile, and if not, how should it be handled to maintain infection control standards?

The Dale Ace Connector is supplied as a non-sterile single-use accessory. To maintain infection control standards, it must be handled with standard aseptic techniques, including proper cleaning of the patient’s skin and tube insertion site before use, and adherence to facility-specific protocols for enteral feeding to prevent contamination.

How is the Dale Ace Connector regulated, and what advisory committees were involved in its review?

The Dale Ace Connector is regulated under FDA 510K clearance and the EU Medical Device Regulation (MDR). Its review was conducted by the Gastroenterology and Urology (GU) advisory committees under the FDA’s Traditional 510(k) pathway, with a product code of KNT assigned for classification.

Can the Dale Ace Connector be reused, or is it designed for single-use only?

The Dale Ace Connector is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, integrity, and patient safety during enteral feeding.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dale Medical Products, Inc.

Sources (2)

  • FDA 510(k) K082241 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026