Cleared Traditional

K172457 - Deltex Medical CardioQ-EDM+

K172457 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 318-day FDA review.

K172457 · Deltex Medical Limited · Cardiovascular device
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Jun 2018
Decision
318d
Days
Class 2
Risk

K172457 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 June 28, 2018 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Deltex Medical Limited devices

FDA 510(k) Submission Details - K172457

510(k) Number K172457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date June 28, 2018
Days to Decision 318 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
193d slower than avg
Panel avg: 125d · This submission: 318d
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 Peers - DPW Flowmeter, Blood, Cardiovascular

All 40
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K172457.
FloPatch (FP110)
K191388 · Flosonics Medical (R/A 1929803 Ontario Corp.) · Jun 2019
FlowMet-R
K182494 · Laser Associated Sciences, Inc. · Feb 2019
iCertainty
K181269 · Rfpi · Dec 2018
MONITOR, MODEL HSM-00200
K031153 · Arrow Intl., Inc. · Nov 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · Terumo Cardiovascular Systems Corp. · May 2003
MS DISPOSABLE RIGID DOPPLER PROBE
K930227 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1993