# K220165: Enteral Transition Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: GBUK Group, Ltd.
- Decided: Oct 21, 2022 after 274 days
- Product code: PIO (Enteral Specific Transition Connectors)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.

Source page: https://510kreport.com/device/K220165
Methodology: https://510kreport.com/methodology