Cleared Traditional

K022596 - BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)

K022596 is an FDA 510(k) clearance for BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM ..., manufactured by Clover Hi-Tech, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K022596 · Clover Hi-Tech, Inc. · Cardiovascular device
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Jan 2003
Decision
179d
Days
Class 2
Risk

K022596 is an FDA 510(k) clearance for the BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Clover Hi-Tech, Inc. (City Of Industry, US). The FDA issued a Cleared decision on January 31, 2003 after a review of 179 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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.

FDA 510(k) Submission Details - K022596

510(k) Number K022596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2002
Decision Date January 31, 2003
Days to Decision 179 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 436
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K022596 · BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
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