# K043235: Dragon Heart I.V. Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Dragon Heart Medical Devices Co., Ltd.
- Decided: Mar 8, 2005 after 106 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073444: Triton Meidcal Tmed IV-Set (2008), 0 descendants of its own

## Indications for use
The Dragon Heart Intravascular Administration Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

Source page: https://510kreport.com/device/K043235
Methodology: https://510kreport.com/methodology