Cleared Traditional

CARDIOSET (HARDWARE), MODEL HO4 (K001091) - FDA 510(k) Clearance

Also marketed or referenced as:
CARDIOSET SCL (SOFTWARE), MODEL V3.01

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001091 · Next Millennium Software Solutions, Inc. · Cardiovascular device
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Aug 2000
Decision
128d
Days
Class 2
Risk

K001091 is an FDA 510(k) clearance for the CARDIOSET (HARDWARE), MODEL HO4. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Next Millennium Software Solutions, Inc. (Hialeah, US). The FDA issued a Cleared decision on August 10, 2000 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Next Millennium Software Solutions, Inc. devices

Submission Details

510(k) Number K001091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2000
Decision Date August 10, 2000
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 54
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