# K120384: Protector, Injector, Connector

- Pathway: 510(k) (Traditional)
- Applicant: Bd Medical-Medical Surgical Systems
- Decided: Sep 12, 2012 after 218 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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 K883614 (1988). 11 ancestors in all.
35 later devices descend from it; 1 cites it directly.
1 of 47 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972527: Phaseal, System for Sealed Handling of Chemotherapeutic Agents, Quality System Consulting (1997) Summary page 1.
- K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter, Carmel Pharma Ab. (2000) Summary page 1.
- K090634: Phaseal Protector P14, P21, P28 and P50, Carmel Pharma Ab. (2009) Summary page 1.
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro, Carmel Pharma Ab. (1998) Summary page 1.
- K023747: Phaseal, Carmel Pharma Ab. (2002) Summary page 1.
- K060866: Phaseal - Closed System for the Preparation and Administration of Parenteral Drugs, Carmel Pharma Ab. (2006) Summary page 1.
- K092782: Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35,, Carmel Pharma Ab. (2009) Summary page 1.
- K110023: Infusion Adapter C100, Carmel Pharma Ab. (2011)

## Most influential descendants
- K123213: BD Phaseal Closed System Transfer Device (2013), 34 descendants of its own
- K130197: BD Phaseal Closed System Transfer Device - P55 (2013), 19 descendants of its own
- K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- K132899: Equashield Closed System Drug Transfer Device (CSTD) (2014), 6 descendants of its own

## Indications for use
The PhaSeal system is a closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of, drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal Protector also prevents microbial ingress.

Source page: https://510kreport.com/device/K120384
Methodology: https://510kreport.com/methodology