Cleared Traditional

K040313 - HRV TOOLS

K040313 is an FDA 510(k) clearance for HRV TOOLS, manufactured by Del Mar Reynolds Medical, Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K040313 · Del Mar Reynolds Medical, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
57d
Days
Class 2
Risk

K040313 is an FDA 510(k) clearance for the HRV TOOLS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Del Mar Reynolds Medical, Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on April 6, 2004 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040313

510(k) Number K040313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2004
Decision Date April 06, 2004
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 539
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K040313.
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
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CMI MAGNETOCARDIOGRAPH
K033488 · Cmi Cardiomag Imaging, Inc. · Jul 2004
CARDIOVIT AT-102
K031557 · Schiller AG · Apr 2004
AUDICOR UPGRADE SYSTEM
K032145 · Inovise Medical, Inc. · Oct 2003
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
K032200 · Remco Italia S.P.A. · Oct 2003
CARDIODIRECT, MODELS 12M, 12I, 12S
K024283 · Reynolds Medical , Ltd. · Aug 2003
K040313 · HRV TOOLS
Download PDF FDA Summary Del Mar Reynolds Medi…