Cleared Traditional

K042002 - SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

K042002 is an FDA 510(k) clearance for SYNESCOPE, manufactured by Ela Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K042002 · Ela Medical, Inc. · Cardiovascular device
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Oct 2004
Decision
86d
Days
Class 2
Risk

K042002 is an FDA 510(k) clearance for the SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Ela Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 20, 2004 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ela Medical, Inc. devices

FDA 510(k) Submission Details - K042002

510(k) Number K042002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2004
Decision Date October 20, 2004
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

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 Peers - DQK Computer, Diagnostic, Programmable

All 374
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K042002.
CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
K042849 · Cardiobiomedical Corporation · Jan 2005
HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
K042148 · Ge Medical Syst. Information Technologies · Dec 2004
QRS-CARD CARDIOLOGY SUITE
K042799 · Pulse Biomedical, Inc. · Oct 2004
ENSITE SYSTEM, MODEL EE3000
K042493 · Endocardial Solutions, Inc. · Oct 2004
HOLTER PLUS
K042463 · Rozinn Electronics, Inc. · Sep 2004
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513 · Ge Medical Systems Information Technologies · Oct 2003