Cleared Traditional

K863535 - LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONI...

K863535 is an FDA 510(k) clearance for LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONI..., manufactured by Computerized Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K863535 · Computerized Medical Systems, Inc. · Cardiovascular device
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Jan 1987
Decision
117d
Days
Class 2
Risk

K863535 is an FDA 510(k) clearance for the LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Computerized Medical Systems, Inc. (Northbrook, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Computerized Medical Systems, Inc. devices

FDA 510(k) Submission Details - K863535

510(k) Number K863535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1986
Decision Date January 06, 1987
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 280
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K863535.
ELECTROCARDIOGRAPH
K865031 · Nihon Kohden America, Inc. · Feb 1987
CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
K863100 · Honeywell, Inc. · Feb 1987
MINGOGRAF 410
K864009 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODIFICATION TO DYNASCOPE SERIES MONITORS
K863914 · Fukuda Denshi USA, Inc. · Jan 1987
MODEL 456 ELECTROCARDIORECORDER RECORDER
K863652 · Del Mar Avionics · Dec 1986
630C ELECTROCARDIOGRAPH
K863030 · Quinton, Inc. · Nov 1986