# K142989: Mini ONE Enteral Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Jan 29, 2015 after 105 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971757 (1997). 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)
- K971757: Low Profile Feeding Set Accessory, Applied Medical Technologies (1997) Summary page 4.

## Recalls of this device
- Nov 26, 2024 · Class II · Z-0819-2025: The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit

## Indications for use
The Mini ONE® Enteral Extension Set is intended for use as an extension set for the Mini ONE® Gastrostomy Button, G-Jet Gastrojejunal Feeding Tube, Mic-Key® Secure-Lok® feeding devices, or other compatible enteral feeding devices. The extension set is for administering feeding, medications, and decompression to compatible devices.

Source page: https://510kreport.com/device/K142989
Methodology: https://510kreport.com/methodology