# K242133: Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)

- Pathway: 510(k) (Special)
- Applicant: Centerline Biomedical, Inc.
- Decided: Oct 11, 2024 after 81 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K926514 (1993). 92 ancestors in all.
3 later devices descend from it; 1 cites it directly.
5 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190106: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle, Centerline Biomedical, Inc. (2019) Summary page 5.
- K230309: Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1), Centerline Biomedical, Inc. (2023) Summary page 5.

## Most influential descendants
- K243842: Intra-Operative Positioning System (IOPS®) (2025), 2 descendants of its own
- K261329: Intra-Operative Positioning System (IOPS) (MC-1);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) (2026), 0 descendants of its own
- 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) (2026), 0 descendants of its own

## Recalls of this device
- Apr 11, 2025 · Class I · Z-1760-2025: Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

## Indications for use
The IOPS (Intra-Operative Positioning 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 descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

Source page: https://510kreport.com/device/K242133
Methodology: https://510kreport.com/methodology