# K042500: Duopross Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Duopross Meditech Corporation
- Decided: Feb 22, 2005 after 161 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 K000572 (2000). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020623: Duopro Safety Syringe (Duopross), M.K. Meditech Co., Ltd. (2002) Summary page 2.
- K022806: Duopro Safety Syringe (Duopross), M.K. Meditech Co., Ltd. (2002) Summary page 2.
- K031594: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray, M.K. Meditech Co., Ltd. (2003) Summary page 2.
- K034031: 10 ML Bak'snap Duopross Retractable Safety Syringe, M.K. Meditech Co., Ltd. (2004) Summary page 2.
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 2.

## Most influential descendants
- K060211: Wuzhou Syringe, with/Without Needle (2006), 3 descendants of its own
- K222925: Hypodermic Syringes & Needle (2023), 0 descendants of its own
- K222124: Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle (2022), 0 descendants of its own
- K210103: Safeway, Lifelong Premium, Lifelong Matrix (2021), 0 descendants of its own

## Indications for use
The 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body. The DuoPross Syringes device is used to inject fluids into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K042500
Methodology: https://510kreport.com/methodology