# K133097: E-Z Link

- Pathway: 510(k) (Traditional)
- Applicant: Duoject Medical Systems, Inc.
- Decided: Mar 13, 2014 after 164 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K894177 (1989). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070584: Smart-Rod, Duoject Medical Systems, Inc. (2008) Summary page 1.
- K041691: Clip 'N'ject Reconstitution System (Clip 'N'ject, West Pharmaceutical Services, Inc. (2004) Summary page 1.

## Most influential descendants
- K161800: OnSite-IV (2016), 0 descendants of its own

## Indications for use
Single use, sterile device for preparation of drugs in a standard vial using liquid from a standard luer syringe to transfer the prepared drug back into the syringe for delivery.

Source page: https://510kreport.com/device/K133097
Methodology: https://510kreport.com/methodology