Cleared Special

Intra-Operative Positioning System (IOPS®) (MC-1) (K230309) - FDA 510(k) Clearance

Also marketed or referenced as:
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)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230309 · Centerline Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
138d
Days
Class 2
Risk

K230309 is an FDA 510(k) clearance for the Intra-Operative Positioning System (IOPS®) (MC-1). 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 June 21, 2023 after a review of 138 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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, Inc. devices

Submission Details

510(k) Number K230309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2023
Decision Date June 21, 2023
Days to Decision 138 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Modification to existing cleared device.

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 183
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