Cleared Traditional

K850136 - CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM

K850136 is an FDA 510(k) clearance for CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM, manufactured by Cardio Data. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K850136 · Cardio Data · Cardiovascular device
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Feb 1985
Decision
18d
Days
Class 2
Risk

K850136 is an FDA 510(k) clearance for the CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Cardio Data (Malboro, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardio Data devices

FDA 510(k) Submission Details - K850136

510(k) Number K850136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date February 01, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
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 314
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K850136.
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · Fukuda Denshi USA, Inc. · Apr 1985
BRENTWOOD EZ SCAN 200 AMBULATORY ECG
K842976 · Brentwood Instruments, Inc. · Mar 1985
ARRHYTHMIA SYSTEM AC-11
K841084 · Fukuda Denshi USA, Inc. · Feb 1985
HORIZON ECG SYSTEM
K823844 · Beckman Instruments, Inc. · Jan 1985
SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
K840899 · Litton Medical Electronics · Nov 1984
EPICARDIA, PC
K843513 · Medicomp, Inc. · Oct 1984