Intra-Operative Positioning System (IOPS) (MC-1) +7 more— 510(k) K261329

Name: FDA 510(k) clearance K261329
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Substantially Equivalent

Centerline Biomedical

FDA 510(k) clearance K261329 for Intra-Operative Positioning System (IOPS) (MC-1) +7 more, Substantially Equivalent on 2026-06-10. Applicant: Centerline Biomedical. Device class: 2.

Summary

Centerline Biomedical's clearance covers the Intra-Operative Positioning System (IOPS, MC-1) and seven other IOPS items: four Viewpoint catheters (Simple Curve and Double Curve, each in 75cm and 125cm), Guidewire 2 (ATW-2), a Fiducial Tracking Pad (T02111), and a Guidewire Handle (H01035). They're filed under DQK, programmable diagnostic computers.

Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).

Centerline filed from Warrensville Heights, Ohio. The decision came 49 calendar days after receipt (April 22 to June 10, 2026).

Clearance details

Device name as filed: 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)
Applicant: Centerline Biomedical
Product code: Product code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2026-04-22
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Warrensville Heights, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

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K261886 — VIVO (9002)2026-10-30
K254226 — PulseAPI SmartWatch2026-10-27
K263380 — STAR Apollo Mapping System2026-10-23
K263016 — Intra-Operative Positioning System (IOPS) and IOPS Visionary System2026-10-01
K254255 — S-Patch CardioAI2026-09-25

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, 2020-01-01 through 2026-04-23. 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.