# K981089: Tissomat and Spray Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 5, 2000 after 833 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: 3 generations back to K872565 (1987). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973510: Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML), Immuno-U.S., Inc. (1997) Summary page 1.

## Most influential descendants
- K050495: Easyspray and Spray Set for Tisseel (Fiber Sealant) (2005), 0 descendants of its own
- K041504: Hemamyst Surgical Applicator System, Model H-AS01 (2004), 0 descendants of its own
- K030032: Crosseal Application Device (2003), 0 descendants of its own

## Indications for use
The Tissomat® and Spray Set are intended for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. The Spray Set is attached to the Duploject® two-syringe holder and is equipped with a Spray Head and a connection tube which connects the Spray Head to the Tissomat® device, a propellant gas control device.

Source page: https://510kreport.com/device/K981089
Methodology: https://510kreport.com/methodology