# K232046: Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

- Pathway: 510(k) (Traditional)
- Applicant: Xeridiem Medical Devices, A Spectrum Plastics Group Company
- Decided: Oct 6, 2023 after 88 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: 5 generations back to K901501 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180708: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX  Low Profile Gastrostomy Feeding Tube, PromaX  LP Patient Care Kit with ENFit, Xeridiem Medical Devices, A Spectrum Plastics Group Company (2018) Summary page 4.

## Indications for use
The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration, or decompression through an established gastrointestinal stoma tract. The Kangaroo Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatric patients that require enteral feeding, medication administration, or decompression through a Kangaroo Skin Level Device.

Source page: https://510kreport.com/device/K232046
Methodology: https://510kreport.com/methodology