# K023747: Phaseal

- Pathway: 510(k) (Special)
- Applicant: Carmel Pharma Ab.
- Decided: Nov 15, 2002 after 7 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: 3 generations back to K883614 (1988). 6 ancestors in all.
38 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)
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro, Carmel Pharma Ab. (1998) Summary page 1.
- K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter, Carmel Pharma Ab. (2000)

## Most influential descendants
- K110023: Infusion Adapter C100 (2011), 37 descendants of its own
- 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

## Indications for use
The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.

Source page: https://510kreport.com/device/K023747
Methodology: https://510kreport.com/methodology