# Q Core Medical, Ltd.

- Location (FDA's records): Gaithersburg, MD
- FDA decisions: 5 (2013–2020): 5 510(k) clearances
- Product codes: FRN (4), FPA (1)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Caesarea Medical Electronics, Ltd.: 2 (https://510kreport.com/company/caesarea-medical-electronics)
- Q-Core, Ltd.: 1 (https://510kreport.com/company/q-core)
- Sigma Intl.: 1 (https://510kreport.com/company/sigma-intl)
- Sims Deltec, Inc.: 1 (https://510kreport.com/company/sims-deltec)
- Hospira, Inc.: 1 (https://510kreport.com/company/hospira)

## Firms that cite its devices most
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Hospira, Inc.: 1 (https://510kreport.com/company/hospira)
- Eitan Medical, Ltd.: 1 (https://510kreport.com/company/eitan-medical)

## Its most-cited devices
- K123049: Sapphire Infusion Pump (2013), cited by 5
- K141389: Sapphire Infusion Pump (2014), cited by 2
- K192860: Sapphire Infusion Pump, Sapphire administration sets (2020), cited by 1
- K161667: Sapphire Infusion Pump (2017), cited by 1

## Recent decisions
- K192860: Sapphire Infusion Pump, Sapphire administration sets (Nov 19, 2020)
- K161667: Sapphire Infusion Pump (Mar 27, 2017)
- K141389: Sapphire Infusion Pump (Dec 11, 2014)
- K141834: Sapphire Administration Set (Aug 5, 2014)
- K123049: Sapphire Infusion Pump (Oct 17, 2013)

Source page: https://510kreport.com/company/q-core-medical