# K200082: BD Univia RightFit Enteral Extension Sets and Transitional Adapters

- Pathway: 510(k) (Traditional)
- Applicant: Mps Medical, Inc.
- Decided: Jul 30, 2020 after 197 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific 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
Longest line of descent: 6 generations back to K801558 (1980). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180236: VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES), Vr Medical Technology Co., Ltd. (2019) Summary page 4.

## Indications for use
BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric/orogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements. BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.

Source page: https://510kreport.com/device/K200082
Methodology: https://510kreport.com/methodology