Cleared Traditional

K113306 - CARDIO 7

K113306 is an FDA 510(k) clearance for CARDIO 7, manufactured by Bionet Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K113306 · Bionet Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
250d
Days
Class 2
Risk

K113306 is an FDA 510(k) clearance for the CARDIO 7. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Bionet Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on July 16, 2012 after a review of 250 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 Bionet Co., Ltd. devices

FDA 510(k) Submission Details - K113306

510(k) Number K113306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2011
Decision Date July 16, 2012
Days to Decision 250 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
125d slower than avg
Panel avg: 125d · This submission: 250d
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 280
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K113306.
ELI 280 ELECTROCARDIOGRAPH
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K120865 · Mortara Instrument, Inc. · Jul 2012
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K113144 · Philips Medical Systems · Apr 2012
ELECTROCARDIOGRAPH
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ACG-8511 PORTABLE ECG MONITOR
K110328 · Andon Health Co, Ltd. · Jul 2011