# K020623: Duopro Safety Syringe (Duopross)

- Pathway: 510(k) (Traditional)
- Applicant: M.K. Meditech Co., Ltd.
- Decided: May 2, 2002 after 65 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: 1 generation back to K000572 (2000). 2 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003348: E.N.S.I. Retractable Safety Syringe, Ensi-Med International Pty., Ltd. (2001) Summary page 1.
- K000572: E.N.S.I. Syringe, Tri-Ject Intl. Corp. (2000) Summary page 1.

## Most influential descendants
- K022806: Duopro Safety Syringe (Duopross) (2002), 24 descendants of its own
- K031594: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray (2003), 15 descendants of its own
- K050131: Insosafe Bak'snap Retractable Insulin Safety Syringe (2005), 8 descendants of its own
- K034031: 10 ML Bak'snap Duopross Retractable Safety Syringe (2004), 6 descendants of its own
- K152808: U&U Insulin Syringe with/without Safety Retractable Device (2016), 5 descendants of its own

## Indications for use
The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is 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/K020623
Methodology: https://510kreport.com/methodology