Cleared Traditional

K170154 - Creavo Vitalscan Magnetocardiograph

K170154 is an FDA 510(k) clearance for Creavo Vitalscan Magnetocardiograph, manufactured by Creavo Medical Technologies, Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K170154 · Creavo Medical Technologies, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
267d
Days
Class 2
Risk

K170154 is an FDA 510(k) clearance for the Creavo Vitalscan Magnetocardiograph. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Creavo Medical Technologies, Ltd. (Coventry, GB). The FDA issued a Cleared decision on October 12, 2017 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

FDA 510(k) Submission Details - K170154

510(k) Number K170154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2017
Decision Date October 12, 2017
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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

Halloran Consulting Group, LLC
Sharon L. Timberlake

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 - DPS Electrocardiograph

All 475
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K170154.
CONTEC™ Electrocardiograph
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CARDIOVIT FT-1
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CardioLogs ECG Analysis Platform
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