# K070584: Smart-Rod

- Pathway: 510(k) (Traditional)
- Applicant: Duoject Medical Systems, Inc.
- Decided: Apr 2, 2008 after 398 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: 3 generations back to K894177 (1989). 7 ancestors in all.
2 later devices descend 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)
- K041691: Clip 'N'ject Reconstitution System (Clip 'N'ject, West Pharmaceutical Services, Inc. (2004) Summary page 1.
- K963012: Bioject Needle-Free Vial Adapter (13MM), Bioject, Inc. (1996) Summary page 1.
- K043304: Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01, Bioject Medical Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K133097: E-Z Link (2014), 1 descendant of its own
- K161800: OnSite-IV (2016), 0 descendants of its own

## Indications for use
The Smart-RodTM is a single use reconstitution device intended for the transfer of a diluent contained in a prefilled syringe to a vial containing a drug product, and the return transfer of the admixture to the syringe. The Smart-RodTM is intended for use by physicians, nurses, and other practitioners who routinely administer injections, or patients and other individuals authorized by a physician to administer injections of prescribed medication.

Source page: https://510kreport.com/device/K070584
Methodology: https://510kreport.com/methodology