Cleared Traditional

K150347 - Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+

K150347 is an FDA 510(k) clearance for Deltex Medical CardioQ-EDM, manufactured by Deltex Medical Limited. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K150347 · Deltex Medical Limited · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
163d
Days
Class 2
Risk

K150347 is an FDA 510(k) clearance for the Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Deltex Medical Limited (Chichester, GB). The FDA issued a Cleared decision on July 24, 2015 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 - K150347

510(k) Number K150347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2015
Decision Date July 24, 2015
Days to Decision 163 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
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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

Meddiquest Limited
Neil Armstrong

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 - DPW Flowmeter, Blood, Cardiovascular

All 95
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