# K192860: Sapphire Infusion Pump, Sapphire administration sets

- Pathway: 510(k) (Traditional)
- Applicant: Q Core Medical, Ltd.
- Decided: Nov 19, 2020 after 412 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904518 (1990). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161667: Sapphire Infusion Pump, Q Core Medical, Ltd. (2017) Summary page 4.
- K141389: Sapphire Infusion Pump, Q Core Medical, Ltd. (2014) Summary page 4.
- K123049: Sapphire Infusion Pump, Q Core Medical, Ltd. (2013) Summary page 4.

## Most influential descendants
- K213744: Avoset Infusion Pump System (2023), 0 descendants of its own

## Recalls of this device
- Sep 11, 2023 · Class I · Z-0094-2024: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

## Indications for use
The Sapphire Infusion pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial, perineural and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood and blood products. The Sapphire Infusion pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. It is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home. The pump is intended to be used by both licensed health care professionals and by lay users. The Sapphire and the administration sets are indicated for use by both adult and pediatric populations. The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.

Source page: https://510kreport.com/device/K192860
Methodology: https://510kreport.com/methodology