# K082241: The Dale Ace Connector (Access Controller for Enteral), Model H84104751

- Pathway: 510(k) (Traditional)
- Applicant: Dale Medical Products, Inc.
- Decided: Oct 30, 2008 after 84 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915171 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915171: Lopez Valve TM  II, Icu Medical, Inc. (1992) Summary page 1.

## Indications for use
The Dale® ACE* Connector (*Access Controller for Enteral) is indicated for controlling fluid flow into and out of medical tubes while providing for the delivery of enteral formula, syringe irrigation, and liquid medication, without breaking the fluid delivery lines for up to 30 days. This closed system protects the healthcare worker from accidental exposure to the patient's gastric fluids.

Source page: https://510kreport.com/device/K082241
Methodology: https://510kreport.com/methodology