Cleared Special

K263016 - Intra-Operative Positioning System (IOPS) and IOPS Visionary System

K263016 is an FDA 510(k) clearance for Intra-Operative Positioning System (IOP..., manufactured by Centerline Biomedical. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 34-day FDA review.

K263016 · Centerline Biomedical · Cardiovascular device
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Oct 2026
Decision
34d
Days
Class 2
Risk

K263016 is an FDA 510(k) clearance for the Intra-Operative Positioning System (IOPS) and IOPS Visionary System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Centerline Biomedical (Warrensville Heights, US). The FDA issued a Cleared decision on October 1, 2026 after a review of 34 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Centerline Biomedical devices

FDA 510(k) Submission Details - K263016

510(k) Number K263016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2026
Decision Date October 01, 2026
Days to Decision 34 days
Submission Type Special
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
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

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 395
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