Cleared Traditional

K041031 - CARDIOSTATION-100 (CS-100)

K041031 is an FDA 510(k) clearance for CARDIOSTATION-100 (CS-100), manufactured by Us Clover Co.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K041031 · Us Clover Co. · Cardiovascular device
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Jan 2005
Decision
280d
Days
Class 2
Risk

K041031 is an FDA 510(k) clearance for the CARDIOSTATION-100 (CS-100). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Us Clover Co. (City Of Industry, US). The FDA issued a Cleared decision on January 26, 2005 after a review of 280 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 - K041031

510(k) Number K041031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2004
Decision Date January 26, 2005
Days to Decision 280 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
155d slower than avg
Panel avg: 125d · This submission: 280d
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 435
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K041031 · CARDIOSTATION-100 (CS-100)
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