Cleared Traditional

K254089 - IOPS Visionary System (MC-3) (FDA 510(k) Clearance)

Also includes:
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)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K254089 · Centerline Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
60d
Days
Class 2
Risk

K254089 is an FDA 510(k) clearance for the IOPS Visionary System (MC-3). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Centerline Biomedical, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 17, 2026 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Centerline Biomedical, Inc. devices

Submission Details

510(k) Number K254089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date February 17, 2026
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 426
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