# K150486: Halo

- Pathway: 510(k) (Traditional)
- Applicant: J & J Solutions, Inc. D/B/A/ Corvida Medical
- Decided: Jul 24, 2015 after 150 days
- Product code: ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K883614 (1988). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123213: BD Phaseal Closed System Transfer Device, Becton, Dickinson & CO (2013) Summary page 5.
- K130197: BD Phaseal Closed System Transfer Device - P55, Becton, Dickinson and Company (2013) Summary page 5.
- K140591: BD Phaseal Closed System Transfer Device - Injector, Becton, Dickinson & CO (2014) Summary page 5.

## Most influential descendants
- K180574: Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor (2018), 0 descendants of its own

## Recalls of this device
- Nov 22, 2016 · Class II · Z-1003-2017: Product malfunction: Needle does not retract.

## Indications for use
The Halo system is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The Halo system also prevents microbial ingress for up to 168 hours.

Source page: https://510kreport.com/device/K150486
Methodology: https://510kreport.com/methodology