# K020666: Duploject Easy-Prep System 1ML, 2ML, 5ML

- Pathway: 510(k) (Abbreviated)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 24, 2002 after 115 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K872565 (1987). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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.
- K992351: Sealouette Fibrin Sealant Applicator, Biosurgical Corp. (1999) Summary page 1.
- K001831: Needleless Transfer Device, Medimop Medical Projects, Ltd. (2000)

## Most influential descendants
- K071126: Cryoseal FS Applicator System (2007), 0 descendants of its own

## Recalls of this device
- Oct 25, 2007 · Not classified · Z-0263-2008: Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid.

## Indications for use
The DUPLOJECT EASY-PREP System is indicated for the preparation and application of TISSEEL VH Fibrin Sealant.

Source page: https://510kreport.com/device/K020666
Methodology: https://510kreport.com/methodology