Cleared Traditional

K853209 - COMPAS 1

K853209 is an FDA 510(k) clearance for COMPAS 1, manufactured by Cardiac Care Units, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K853209 · Cardiac Care Units, Inc. · Cardiovascular device
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Nov 1985
Decision
97d
Days
Class 2
Risk

K853209 is an FDA 510(k) clearance for the COMPAS 1. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Cardiac Care Units, Inc. (Van Nuys, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 97 days - within the typical 510(k) review window.

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 Cardiac Care Units, Inc. devices

FDA 510(k) Submission Details - K853209

510(k) Number K853209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1985
Decision Date November 05, 1985
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 K853209.
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · Fukuda Denshi USA, Inc. · Feb 1986
MEDILOG M6
K852892 · Oxford Medilog, Inc. · Dec 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352 · Fukuda Denshi USA, Inc. · Nov 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213 · Fukuda Denshi USA, Inc. · Oct 1985
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · Hewlett-Packard Co. · Sep 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270 · Nihon Kohden America, Inc. · Jul 1985