# K101368: D. Heart Medical Intravascular Administration Set, Safety Acces Device and Accessories

- Pathway: 510(k) (Abbreviated)
- Applicant: Dragon Heart Medical, Inc.
- Decided: Nov 18, 2010 after 185 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
D. Heart Medical intravascular administration set, safety access device and accessories are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Each device is comprised of components commonly found in intravascular administration sets and extension sets. Incorporation of safety access device aid in the prevention of accidental needle sticks to healthcare workers and patients.

Source page: https://510kreport.com/device/K101368
Methodology: https://510kreport.com/methodology