# K082212: Syringe with Handi-Fil

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
- Decided: Jan 22, 2009 after 169 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K860204 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963071: Angiomat Illumena, Mallinckrodt Inc., Liebel-Flarsheim Business (1997) Summary page 2.

## Indications for use
The Syringe with Handi-Fil is part of the contrast delivery system which is designed to inject radiopaque contrast media and/or saline into the vascular system for Angiographic or CT procedures as prescribed by qualified healthcare professionals

Source page: https://510kreport.com/device/K082212
Methodology: https://510kreport.com/methodology