# K142367: Hospira Primary Sets

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Nov 25, 2014 after 92 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K030467 (2003). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal, Hospira, Inc. (2012) Summary page 4.
- K101677: Hospira Infusion Blood Sets, Hospira, Inc. (2010) Summary page 4.

## Most influential descendants
- K143015: Hospira Primary Sets (2015), 3 descendants of its own
- K160870: Hospira Administration Sets (2016), 1 descendant of its own
- K192375: Intellifuse Administration and Intellifuse Blood Administration Sets (2020), 0 descendants of its own
- K161036: Hospira Extension Set, Hospira Primary Set (2017), 0 descendants of its own

## Recalls of this device
- May 12, 2026 · Class II · Z-3160-2026: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber 

## Indications for use
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/K142367
Methodology: https://510kreport.com/methodology