# K041830: Magellan Ratio Dispenser Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Perfusion Systems
- Decided: Sep 29, 2004 after 84 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883338 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020147: Magellan Ratio Dispenser Kit/Magellan Spray Tip/Magellan Cannula Tip, Medtronic Perfusion Systems (2002) Summary page 1.
- K020252: Smartjet Grafting Liquid Applicator, Models SK/S & LK/2, Harvest Technologies, Corp. (2002) Summary page 1.

## Indications for use
The Magellan Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair.

Source page: https://510kreport.com/device/K041830
Methodology: https://510kreport.com/methodology