Cleared Traditional

Intra-Operative Positioning System (K190106) - FDA 510(k) Clearance

Also marketed or referenced as:
Simple Curve Catheter, Reverse Curve Catheter Angled Tip Guidewire Tracking Pad Guidewire Handle

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

K190106 · Centerline Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
153d
Days
Class 2
Risk

K190106 is an FDA 510(k) clearance for the Intra-Operative Positioning System. 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 24, 2019 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Centerline Biomedical, Inc. devices

Submission Details

510(k) Number K190106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2019
Decision Date June 24, 2019
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
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 Consultant

Jalex Medical
Lauren Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 183
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K190106.
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VIVO
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Edwards Pressure Cable
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