# K254089: IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)

- Pathway: 510(k) (Traditional)
- Applicant: Centerline Biomedical, Inc.
- Decided: Feb 17, 2026 after 60 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K926514 (1993). 95 ancestors in all.
No later device cites it as a predicate yet.
6 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243842: Intra-Operative Positioning System (IOPS®), Centerline Biomedical, Inc. (2025) Summary page 5.

## Indications for use
The IOPS Visionary System is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously-acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

Source page: https://510kreport.com/device/K254089
Methodology: https://510kreport.com/methodology