Cleared Special

K100813 - QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB

K100813 is an FDA 510(k) clearance for QRS CARD S-T SEGMENT ANALYSIS PATIENT M..., manufactured by Pulse Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 122-day FDA review.

K100813 · Pulse Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
122d
Days
Class 2
Risk

K100813 is an FDA 510(k) clearance for the QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Pulse Biomedical, Inc. (Norristown, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 122 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100813

510(k) Number K100813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2010
Decision Date July 23, 2010
Days to Decision 122 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

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 495
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K100813.
ANS SYSTEM
K101016 · Caird Technology · Jan 2011
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K101115 · Mortara Instrument, Inc. · Jun 2010
CARECENTER MD
K093211 · Cardiac Science Corporation · Jun 2010
K100813 · QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
Download PDF FDA Summary Pulse Biomedical, Inc.