# K110023: Infusion Adapter C100

- Pathway: 510(k) (Traditional)
- Applicant: Carmel Pharma Ab.
- Decided: Apr 12, 2011 after 99 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: 4 generations back to K883614 (1988). 7 ancestors in all.
37 later devices descend from it; 2 cite it directly.
1 of 45 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023747: Phaseal, Carmel Pharma Ab. (2002) Summary page 1.

## 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
The indication for use is admixing of drug into an IV container and administration/transfer of drug from the container to an external IV line, while minimizing exposure to potentially hazardous drugs aerosols and spills

Source page: https://510kreport.com/device/K110023
Methodology: https://510kreport.com/methodology