# K150034: AMT Enteral Transition Adapters

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Jun 9, 2015 after 151 days
- Product code: PIO (Enteral Specific Transition 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: 3 generations back to K940556 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140581: Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port, Cedic S.R.L. (2014) Summary page 4.

## Most influential descendants
- K162254: Cedic Enteral ENFit Transition Connectors (2017), 0 descendants of its own

## Recalls of this device
- Nov 10, 2020 · Class III · Z-0698-2021: The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

## Indications for use
The AMT Enteral Transition Adapters are intended to facilitate enteral specific connections between AAMI/CN3(PS) compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.

Source page: https://510kreport.com/device/K150034
Methodology: https://510kreport.com/methodology