Cleared Traditional

K093172 - QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)

K093172 is an FDA 510(k) clearance for QUANTITATIVE ELECTROCARDIOGRAPHIC DETEC..., manufactured by Dynacardia, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K093172 · Dynacardia, Inc. · Cardiovascular device
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Jan 2010
Decision
104d
Days
Class 2
Risk

K093172 is an FDA 510(k) clearance for the QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Dynacardia, Inc. (Azusa, US). The FDA issued a Cleared decision on January 20, 2010 after a review of 104 days - within the typical 510(k) review window.

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.

View all Dynacardia, Inc. devices

FDA 510(k) Submission Details - K093172

510(k) Number K093172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2009
Decision Date January 20, 2010
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Peers - DPS Electrocardiograph

All 336
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K093172.
SE-601 SERIES ELECTROCARDIOGRAPH
K093869 · Edan Instruments, Inc. · Apr 2010
HANDHELD ECG MONITOR, MODEL MD100
K093872 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2010
ELI PC ELECTROCARDIOGRAPH
K093339 · Mortara Instrument, Inc. · Feb 2010
ELI 350 ELECTROCARDIOGRAPH
K092663 · Mortara Instrument, Inc. · Dec 2009
PC ECG, MODEL SE-1010
K092010 · Edan Instruments, Inc. · Oct 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
K091513 · Edan Instruments, Inc. · Jul 2009