Cleared Traditional

K072950 - CYGNUS 12 LEAD ECG MODULE

K072950 is an FDA 510(k) clearance for CYGNUS 12 LEAD ECG MODULE, manufactured by Cygnus, LLC. The device is a Class 2 Cardiovascular device with product code KRE cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K072950 · Cygnus, LLC · Cardiovascular device
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Aug 2008
Decision
309d
Days
Class 2
Risk

K072950 is an FDA 510(k) clearance for the CYGNUS 12 LEAD ECG MODULE. Classified as Analyzer, Pacemaker Generator Function, Indirect (product code KRE), Class II - Special Controls.

Submitted by Cygnus, LLC (Paterson, US). The FDA issued a Cleared decision on August 22, 2008 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3640 - 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 Cygnus, LLC devices

FDA 510(k) Submission Details - K072950

510(k) Number K072950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2007
Decision Date August 22, 2008
Days to Decision 309 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 125d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRE Device Classification - Class 2, Special Controls

Product Code KRE Analyzer, Pacemaker Generator Function, Indirect
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3640
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 - KRE Analyzer, Pacemaker Generator Function, Indirect

All 7
Devices cleared under the same product code (KRE) and FDA review panel - the closest regulatory comparables to K072950.
PACEART OPTIMA SYSTEM SOFTWARE
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EKG SPEAKS
K032926 · Medtronic Vascular · Oct 2003
HPM 40 HEART PACEMAKER MONITOR
K922742 · Biotronik, GmbH & Co. · Mar 1993
PACEMAKER SYS ANALYZER #384
K833647 · Pacesetter Systems · Dec 1983
PACEMAKER SYS. ANALYZER 378
K832959 · Siemens Elema AB · Nov 1983
CARDIOMEMO
K803286 · Instromedix, Inc. · Mar 1981