Cleared Traditional

K001091 - CARDIOSET (HARDWARE), MODEL HO4

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

K001091 is an FDA 510(k) clearance for CARDIOSET (HARDWARE), manufactured by Next Millennium Software Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 128-day FDA review.

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

FDA 510(k) Submission Details - K001091

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.

DXH Device Classification - Class 2, Special Controls

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 175
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K001091.
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K994009 · Card Guard Scientific Survival , Ltd. · Dec 1999
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