# K964642: Medrad Disposable Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Apr 29, 1997 after 161 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K013815: Medrad Qwik-Fit Syringe (2001), 0 descendants of its own

## Indications for use
The intended use of the proposed device(s) duplicates the predicate device(s), in that, the proposed synthetic rubber cover, a component of the disposable syringe(s) device is used with a powered injector to assist the hospital clinician in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes, to effect computerized tomography, magnetic resonance, and angiographic diagnostic imaging.

Source page: https://510kreport.com/device/K964642
Methodology: https://510kreport.com/methodology