# K092782: Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35,

- Pathway: 510(k) (Traditional)
- Applicant: Carmel Pharma Ab.
- Decided: Dec 7, 2009 after 88 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: 2 generations back to K883614 (1988). 5 ancestors in all.
36 later devices descend from it; 1 cites it directly.
1 of 42 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)

## Most influential descendants
- K120384: Protector, Injector, Connector (2012), 35 descendants of its own
- 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

## Indications for use
Indications for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drug aerosols and spills that can occur during the reconstitution, administration and disposal process.

Source page: https://510kreport.com/device/K092782
Methodology: https://510kreport.com/methodology