# K013815: Medrad Qwik-Fit Syringe

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Dec 13, 2001 after 27 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: 1 generation back to K964642 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964642: Medrad Disposable Syringes, Medrad, Inc. (1997) Summary page 1.

## Indications for use
Medrad Qwik-Fit Syringes are indicated to contain and hold contrast media and assist in delivery of same, to effect CT and MRI diagnostics. They are indicated for single-use only.

Source page: https://510kreport.com/device/K013815
Methodology: https://510kreport.com/methodology