# K090634: Phaseal Protector P14, P21, P28 and P50

- Pathway: 510(k) (Special)
- Applicant: Carmel Pharma Ab.
- Decided: Mar 23, 2009 after 14 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: 1 generation back to K001368 (2000). 1 ancestor in all.
36 later devices descend from it; 1 cites it directly.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter, Carmel Pharma Ab. (2000) 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 reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.

Source page: https://510kreport.com/device/K090634
Methodology: https://510kreport.com/methodology