Cleared Traditional

K910109 - CARDIOSWISS CM-8

K910109 is an FDA 510(k) clearance for CARDIOSWISS CM-8, manufactured by Care Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K910109 · Care Systems, Inc. · Cardiovascular device
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Sep 1991
Decision
256d
Days
Class 2
Risk

K910109 is an FDA 510(k) clearance for the CARDIOSWISS CM-8. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Care Systems, Inc. (Huntsville, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 256 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 Care Systems, Inc. devices

FDA 510(k) Submission Details - K910109

510(k) Number K910109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1991
Decision Date September 23, 1991
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
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 311
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K910109.
ORG-8200A UNIVERSAL SIGNAL HOUSING
K912744 · Nihon Kohden America, Inc. · Dec 1991
TYPE 9210 S/ECG
K903940 · S & W Medico Teknik · Dec 1991
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
K913451 · Hewlett-Packard Co. · Oct 1991
ACCUCORE TELEMETRY, MODIFICATION
K905506 · S & W Medico Teknik · Sep 1991
Q-SMART HOLTER SYSTEMS
K910808 · Quinton, Inc. · Jul 1991
ARRHYTHMIA 9215
K900366 · S & W Medico Teknik · Apr 1991