# K153760: Volumetric Infusion Controller

- Pathway: 510(k) (Traditional)
- Applicant: DEKA Research & Development
- Decided: Oct 3, 2016 after 278 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: 1 generation back to K863204 (1986). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863204: Deka JR., Deka Research & Development Corp. (1986) Summary page 4.

## Most influential descendants
- K232316: DEKA Infusion System, DEKA Administration Set (2024), 1 descendant of its own
- K242693: DEKA Infusion System, DEKA Administration Set (2024), 0 descendants of its own

## Indications for use
The Volumetric Infusion Controller is intended for the delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion in a clinical setting by a trained medical professional. The device is not intended to administer critical fluids, including high-risk medications.

Source page: https://510kreport.com/device/K153760
Methodology: https://510kreport.com/methodology