# K161036: Hospira Extension Set, Hospira Primary Set

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Jan 6, 2017 after 268 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: 6 generations back to K030467 (2003). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142974: Extension Sets, Hospira, Inc. (2015) Summary page 4.
- K143015: Hospira Primary Sets, Hospira, Inc. (2015) Summary page 4.

## Indications for use
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient’s vascular system. Hospira Primary sets are indicated for the delivery of fluids from a container to a patient’s vascular system.

Source page: https://510kreport.com/device/K161036
Methodology: https://510kreport.com/methodology