Cleared Traditional

K102767 - CARDIO XP

K102767 is an FDA 510(k) clearance for CARDIO XP, 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 252-day FDA review.

K102767 · Bionet Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 2011
Decision
252d
Days
Class 2
Risk

K102767 is an FDA 510(k) clearance for the CARDIO XP. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Bionet Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on June 3, 2011 after a review of 252 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 - K102767

510(k) Number K102767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date June 03, 2011
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
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
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