# K031339: Optibolus

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Inc., Liebel-Flarsheim Business
- Decided: Jul 11, 2003 after 74 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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: 1 generation back to K912944 (1992). 1 ancestor in all.
12 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912944: CT 8000 Digital Injection System, Mallinckrodt Group, Inc. (1992) Summary page 2.

## Most influential descendants
- K042744: Optiv Antage DH Power Injection System (2004), 11 descendants of its own
- K072886: Medrad Stellant CT Injector System with P3T (2007), 7 descendants of its own
- K082905: Medrad Stellant CT Injector System with P3T Cardiac (2009), 5 descendants of its own
- K173773: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (2018), 4 descendants of its own
- K182273: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (2018), 3 descendants of its own

## Recalls of this device
- Apr 14, 2008 · Not classified · Z-1828-2008: The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.

## Indications for use
The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (Le. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.

Source page: https://510kreport.com/device/K031339
Methodology: https://510kreport.com/methodology