# K003348: E.N.S.I. Retractable Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Ensi-Med International Pty., Ltd.
- Decided: Jan 12, 2001 after 78 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
No predicates in its family tree.
27 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020623: Duopro Safety Syringe (Duopross) (2002), 25 descendants of its own
- 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

Source page: https://510kreport.com/device/K003348
Methodology: https://510kreport.com/methodology