# K141834: Sapphire Administration Set

- Pathway: 510(k) (Special)
- Applicant: Q Core Medical, Ltd.
- Decided: Aug 5, 2014 after 29 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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.
- K031749: Bodyguard Infusion System, Caesarea Medical Electronics, Ltd. (2003) Summary page 4.

## Indications for use
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/K141834
Methodology: https://510kreport.com/methodology