# K014088: Duploreach

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 7, 2002 after 177 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 K964597 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992351: Sealouette Fibrin Sealant Applicator, Biosurgical Corp. (1999) Summary page 1.

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

## Indications for use
The DUPLOREACH Extended Applicator, in conjunction with the DUPLOJECT Double-Barreled Syringe Applicator Device, is intended for the mixing and delivery of TISSEEL VH Fibrin Sealant.

Source page: https://510kreport.com/device/K014088
Methodology: https://510kreport.com/methodology