# K822536: MARK V

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Sep 28, 1982 after 35 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.
44 later devices descend from it; 2 cite it directly.
0 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
- K963982: Acist Angiographic Injector (1997), 23 descendants of its own
- K984231: Angiographic Contrast Management System, Model Part a and Part B (2000), 20 descendants of its own
- K984058: Acist Injector System, Model CL100 H (1999), 20 descendants of its own
- K991103: Modification to Acist CL 100H (2000), 19 descendants of its own
- K973334: OZ Power Syringe (1998), 19 descendants of its own

Source page: https://510kreport.com/device/K822536
Methodology: https://510kreport.com/methodology