# K160492: Hospira Sapphire Sets

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Dec 6, 2016 after 288 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904518 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123049: Sapphire Infusion Pump, Q Core Medical, Ltd. (2013) Summary page 4.

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

Source page: https://510kreport.com/device/K160492
Methodology: https://510kreport.com/methodology