Cleared Traditional

K895801 - MAC-LAB CARDIAC CATHETERIZATION LABORAT...

K895801 is the FDA 510(k) clearance for MAC-LAB CARDIAC CATHETERIZATION LABORAT... by Marquette Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K895801 · Marquette Electronics, Inc. · Cardiovascular device
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Apr 1990
Decision
188d
Days
Class 2
Risk

K895801 is an FDA 510(k) clearance for the MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Jupiter, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 188 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Marquette Electronics, Inc. devices

Submission Details

510(k) Number K895801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1989
Decision Date April 04, 1990
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 160
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K895801.
TYPE 9140/NEO
K896700 · S & W Medico Teknik · Apr 1990
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
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MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · Hewlett-Packard Co. · Apr 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080 · Datex Division Instrumentarium Corp. · Mar 1990
ERGOMED 840/ERGOMED 840L
K885085 · Burdick Corp. · Oct 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · Fukuda Denshi USA, Inc. · Oct 1989