# K041919: Perfudrop Air M-P with Needle 20 G, Model 48451606

- Pathway: 510(k) (Abbreviated)
- Applicant: Clinico
- Decided: Oct 4, 2004 after 80 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 K022209 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022209: Alaris Medical Infusion System Administration Sets, Alaris Medical Systems, Inc. (2002) Summary page 1.

## Indications for use
Perfudrop® Air M-P with Needle is an intravascular administration set to administer IV fluids and pharmaceuticals from a container to a patient's vascular system through a needle inserted into a vein. The administration set is for use under gravity and pressure conditions. The set is not intended nor indicated for use with blood or blood products.

Source page: https://510kreport.com/device/K041919
Methodology: https://510kreport.com/methodology