# K123049: Sapphire Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Q Core Medical, Ltd.
- Decided: Oct 17, 2013 after 384 days
- Product code: FRN (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: 4 generations back to K904518 (1990). 15 ancestors in all.
7 later devices descend from it; 5 cite it directly.
4 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082182: AP 34 Multi-Therapy Infusion Pump, Q-Core, Ltd. (2008) Summary page 1.
- K042121: Spectrum and Spectrum with Master Drug Library, Sigma Intl. (2004) Summary page 1.
- K000842: Cadd-Prizm PCS II Model 6101 Ambulatory Infusion System, Sims Deltec, Inc. (2000) Summary page 1.
- K060479: Modification to Bodyguard Infusion Pump System, Caesarea Medical Electronics, Ltd. (2006) Summary page 1.

## Most influential descendants
- K141389: Sapphire Infusion Pump (2014), 3 descendants of its own
- K161667: Sapphire Infusion Pump (2017), 2 descendants of its own
- K192860: Sapphire Infusion Pump, Sapphire administration sets (2020), 1 descendant of its own
- K213744: Avoset Infusion Pump System (2023), 0 descendants of its own
- K171346: Sapphire Sets (2017), 0 descendants of its own

## Indications for use
The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products. The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical ground transportation. 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/K123049
Methodology: https://510kreport.com/methodology