# Carmel Pharma Ab.

- Location (FDA's records): Gothenburg, SE
- FDA decisions: 7 (1998–2011): 7 510(k) clearances
- Product codes: LHI (7)
- Predicates its devices cite: 8 (6 its own); citations of its devices by later devices: 19 (6 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Quality System Consulting: 2 (https://510kreport.com/company/quality-system-consulting)

## Firms that cite its devices most
- Bd Medical-Medical Surgical Systems: 7 (https://510kreport.com/company/bd-medical-medical-surgical-systems)
- Migada Plant: 2 (https://510kreport.com/company/migada-plant)
- Aea Srl: 1 (https://510kreport.com/company/aea)
- Medimop Medical Projects, Ltd.: 1 (https://510kreport.com/company/medimop-medical-projects)
- Yukon Medical, LLC: 1 (https://510kreport.com/company/yukon-medical)
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)

## Its most-cited devices
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro (1998), cited by 7
- K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter (2000), cited by 5
- K023747: Phaseal (2002), cited by 2
- K110023: Infusion Adapter C100 (2011), cited by 2
- K060866: Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs (2006), cited by 1
- K090634: Phaseal Protector P14, P21, P28 and P50 (2009), cited by 1

## Recent decisions
- K110023: Infusion Adapter C100 (Apr 12, 2011)
- K092782: Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35, (Dec 7, 2009)
- K090634: Phaseal Protector P14, P21, P28 and P50 (Mar 23, 2009)
- K060866: Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs (Apr 28, 2006)
- K023747: Phaseal (Nov 15, 2002)
- K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter (May 12, 2000)
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro (Mar 3, 1998)

Source page: https://510kreport.com/company/carmel-pharma