# K171346: Sapphire Sets

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical
- Decided: Aug 25, 2017 after 109 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 9 (0 Class I)
- 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.

## Recalls of this device
- Jul 29, 2019 · Class II · Z-0133-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0134-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0129-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0130-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0131-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0147-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0132-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0135-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Nov 8, 2018 · Class II · Z-0619-2019: There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.

## Indications for use
Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular. Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system. Sapphire Epidural Set are indicated for the delivery of fluids to a patient's epidural space.

Source page: https://510kreport.com/device/K171346
Methodology: https://510kreport.com/methodology