Cleared Traditional

K093211 - CARECENTER MD

K093211 is an FDA 510(k) clearance for CARECENTER MD, manufactured by Cardiac Science Corporation. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K093211 · Cardiac Science Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
233d
Days
Class 2
Risk

K093211 is an FDA 510(k) clearance for the CARECENTER MD. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardiac Science Corporation (Bothell, US). The FDA issued a Cleared decision on June 3, 2010 after a review of 233 days - an extended review 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: 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 Cardiac Science Corporation devices

FDA 510(k) Submission Details - K093211

510(k) Number K093211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2009
Decision Date June 03, 2010
Days to Decision 233 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
108d slower than avg
Panel avg: 125d · This submission: 233d
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 306
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K093211.
ELECTROCARDIOGRAPH
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K101115 · Mortara Instrument, Inc. · Jun 2010
ELI 230 ELECTROCARDIOGRAPH
K100127 · Mortara Instrument, Inc. · Apr 2010
SE-601 SERIES ELECTROCARDIOGRAPH
K093869 · Edan Instruments, Inc. · Apr 2010
HANDHELD ECG MONITOR, MODEL MD100
K093872 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2010