# K050495: Easyspray and Spray Set for Tisseel (Fiber Sealant)

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp., Bioscience
- Decided: May 2, 2005 after 63 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: 4 generations back to K872565 (1987). 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)
- K981089: Tissomat and Spray Set, Baxter Healthcare Corp (2000) Summary page 1.

## Indications for use
The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System

Source page: https://510kreport.com/device/K050495
Methodology: https://510kreport.com/methodology