IOPS Visionary System (MC-3) +7 more— 510(k) K254089
Substantially EquivalentCenterline Biomedical, Inc.
FDA 510(k) clearance K254089 for IOPS Visionary System (MC-3) +7 more, Substantially Equivalent on 2026-02-17. Applicant: Centerline Biomedical, Inc.. Device class: 2.
Summary
Centerline Biomedical lists eight IOPS items: the IOPS Visionary System (MC-3), four IOPS Viewpoint catheters (Simple Curve and Double Curve, each in 75cm and 125cm), the IOPS Guidewire 2, the IOPS Fiducial Tracking Pad, and the IOPS Guidewire Handle. They're filed under product code DQK (Computer, Diagnostic, Programmable). The record doesn't describe the items beyond their names.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Centerline Biomedical filed from Cleveland, Ohio. The decision came 60 calendar days after FDA received it (December 19, 2025 to February 17, 2026), and it was substantially equivalent.
Clearance details
- Device name as filed
- 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)
- Applicant
- Centerline Biomedical, Inc.
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code DQK
view allMore clearances from Centerline Biomedical, Inc.
view all- K243842 — Intra-Operative Positioning System (IOPS®)
- K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad) +1 more
- K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) +1 more
- K230309 — Intra-Operative Positioning System (IOPS®) (MC-1) +4 more
- K190106 — Intra-Operative Positioning System +4 more
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.