Cleared Traditional

K900607 - MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11

K900607 is an FDA 510(k) clearance for MK5 DETECTOR & ALARM, manufactured by Cardiodata Corp.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K900607 · Cardiodata Corp. · Cardiovascular device
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Oct 1990
Decision
250d
Days
Class 2
Risk

K900607 is an FDA 510(k) clearance for the MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Cardiodata Corp. (Northborough, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 250 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Cardiodata Corp. devices

FDA 510(k) Submission Details - K900607

510(k) Number K900607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date October 16, 1990
Days to Decision 250 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 125d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 313
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K900607.
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MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
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FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
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TRAM PATIENT MONITOR
K900540 · Marquette Electronics, Inc. · Jul 1990
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
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