# K232316: DEKA Infusion System, DEKA Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Deka Research and Development
- Decided: Mar 1, 2024 after 211 days
- Product code: LDR (Controller, Infusion, Intravascular, Electronic)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K832284 (1983). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153760: Volumetric Infusion Controller, DEKA Research & Development (2016) Summary page 6.
- K120685: Zyno Medical Administration Set, Zyno Medical, LLC (2012) Summary page 6.

## Most influential descendants
- K242693: DEKA Infusion System, DEKA Administration Set (2024), 0 descendants of its own

## Indications for use
The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician. The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products. The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.

Source page: https://510kreport.com/device/K232316
Methodology: https://510kreport.com/methodology