# K071421: Promepla Intravascular Administration Set and Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Promepla
- Decided: Oct 4, 2007 after 135 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: 2 generations back to K942391 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051499: Intravascular Administration Set and Extension Set, Medegen Medical Manufacturing Services (2005) Summary page 1.
- K970255: Kipp Med I.V. Manifold, The Kipp Group (1997) Summary page 1.

## Indications for use
The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only.

Source page: https://510kreport.com/device/K071421
Methodology: https://510kreport.com/methodology