# K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter

- Pathway: 510(k) (Special)
- Applicant: Carmel Pharma Ab.
- Decided: May 12, 2000 after 11 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
44 later devices descend from it; 5 cite it directly.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023747: Phaseal (2002), 38 descendants of its own
- K110023: Infusion Adapter C100 (2011), 37 descendants of its own
- K092782: Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C, Connector Luer Lock, Model C35, (2009), 36 descendants of its own
- K090634: Phaseal Protector P14, P21, P28 and P50 (2009), 36 descendants of its own
- K120384: Protector, Injector, Connector (2012), 35 descendants of its own

## Recalls of this device
- Jun 26, 2007 · Not classified · Z-1181-2007: Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leaka
- Jun 26, 2007 · Not classified · Z-1180-2007: Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leaka
- Jun 26, 2007 · Not classified · Z-1179-2007: Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leaka
- Jun 26, 2007 · Not classified · Z-1178-2007: Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leaka

Source page: https://510kreport.com/device/K001368
Methodology: https://510kreport.com/methodology