# K093332: Delphi Infusion Pump/ Delphi Administration Set  Model IV-01000/ Model IV-02XXXX (Where X IS Any Number Between 0-9)

- Pathway: 510(k) (Traditional)
- Applicant: Delphi Medical Systems
- Decided: Dec 9, 2009 after 44 days
- Product code: FRN (Pump, Infusion)
- 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: 4 generations back to K904518 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
3 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953896: The Imed Ambulatory Infusion Pump, Administration Sets, Imed Corp. (1996) Summary page 1.
- K042121: Spectrum and Spectrum with Master Drug Library, Sigma Intl. (2004) Summary page 1.

## Indications for use
The Delphi Infusion Pump is intended for use in the controlled delivery of epidural and IV solutions.

Source page: https://510kreport.com/device/K093332
Methodology: https://510kreport.com/methodology