# K973510: Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)

- Pathway: 510(k) (Traditional)
- Applicant: Immuno-U.S., Inc.
- Decided: Dec 8, 1997 after 83 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 K872565 (1987). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872565: Duoflo Dispenser, Hemaedics, Inc. (1987) Summary page 1.
- K964833: Rmi Dual Fluid Irrigating Syringe, Research Medical, Inc. (1997) Summary page 1.
- K881020: Surgical Sealant Dispenser (SSD), Micromedics, Inc. (1988) Summary page 1.

## Most influential descendants
- K981089: Tissomat and Spray Set (2000), 3 descendants of its own
- K020666: Duploject Easy-Prep System 1ML, 2ML, 5ML (2002), 1 descendant of its own
- K071126: Cryoseal FS Applicator System (2007), 0 descendants of its own
- K063535: Caption Applicator (2007), 0 descendants of its own
- K050495: Easyspray and Spray Set for Tisseel (Fiber Sealant) (2005), 0 descendants of its own

## Indications for use
The Duploject® is intended for use in the simuitaneous delivery of two non-homogenous fluids or solutions onto a surgical site. The Duploject® is equipped with a syringe holder, which assures controlled, accurate dispensing, and a needle holder, which allows the contents of the syringes to mix prior to dispensing.

Source page: https://510kreport.com/device/K973510
Methodology: https://510kreport.com/methodology