# K031594: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray

- Pathway: 510(k) (Traditional)
- Applicant: M.K. Meditech Co., Ltd.
- Decided: Jun 6, 2003 after 16 days
- Product code: MEG (Syringe, Antistick)
- 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 K000572 (2000). 5 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 21 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)
- K022806: Duopro Safety Syringe (Duopross), M.K. Meditech Co., Ltd. (2002) Summary page 1.
- K012121: Secureguard Retractable Safety Syringe, Safegard Medical Products, Inc. (2001)

## Most influential descendants
- K050131: Insosafe Bak'snap Retractable Insulin Safety Syringe (2005), 8 descendants of its own
- K152808: U&U Insulin Syringe with/without Safety Retractable Device (2016), 5 descendants of its own
- K042500: Duopross Syringes (2005), 4 descendants of its own
- K060211: Wuzhou Syringe, with/Without Needle (2006), 3 descendants of its own
- K202570: Insulin Syringe, Insulin Syringe with Safety Retractable (2021), 2 descendants of its own

## Indications for use
The 1 mL Bak'Snap DuoProTM Safety Syringe (DuoProSS) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Source page: https://510kreport.com/device/K031594
Methodology: https://510kreport.com/methodology