Cleared Traditional

K062068 - INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0

K062068 is an FDA 510(k) clearance for INTELWAVE HEART RATE VARIABILITY SYSTEM, manufactured by Intelwave, LLC. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K062068 · Intelwave, LLC · Cardiovascular device
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Oct 2006
Decision
98d
Days
Class 2
Risk

K062068 is an FDA 510(k) clearance for the INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Intelwave, LLC (Edison, US). The FDA issued a Cleared decision on October 27, 2006 after a review of 98 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 Intelwave, LLC devices

FDA 510(k) Submission Details - K062068

510(k) Number K062068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2006
Decision Date October 27, 2006
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 354
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K062068.
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K062677 · Mortara Instrument, Inc. · Nov 2006
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K060766 · Omron Healthcare, Inc. · Jun 2006
CARDIOFAX CE, MODEL ECG-1500 A
K052511 · Nihon Kohden America, Inc. · May 2006
PHILIPS 12-LEAD ALGORITHM
K052049 · Philips Medical Systems · Aug 2005