# K050906: Vitalcare I.V. Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Vitalcare Group, Inc.
- Decided: Aug 23, 2005 after 134 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 1 generation back to K925465 (1993). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925465: Teleradiology Device & Component of Pacs Component, Life Care Imaging (1993) Summary page 2.

## Most influential descendants
- K111351: Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set (2011), 7 descendants of its own
- K092715: Iroot BP Plus (2009), 7 descendants of its own
- K121803: Intravascular Administration Set (2012), 4 descendants of its own
- K102867: Iroot FS (2010), 2 descendants of its own
- K240365: Bioceramic Root Repair Material (C-Root BP) (2024), 1 descendant of its own

## Indications for use
The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein,

Source page: https://510kreport.com/device/K050906
Methodology: https://510kreport.com/methodology