Cleared Traditional

K850454 - CARDIO-3 CHANNEL ELECTROCARDIOGRAPH

K850454 is the FDA 510(k) clearance for CARDIO-3 CHANNEL ELECTROCARDIOGRAPH by Zimmer Elektromedizin GmbH. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K850454 · Zimmer Elektromedizin GmbH · Cardiovascular device
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Mar 1985
Decision
23d
Days
Class 2
Risk

K850454 is an FDA 510(k) clearance for the CARDIO-3 CHANNEL ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Zimmer Elektromedizin GmbH (7910 Neu-Ulm, Germany, DE). The FDA issued a Cleared decision on March 1, 1985 after a review of 23 days - a notably fast clearance cycle.

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: 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 Zimmer Elektromedizin GmbH devices

Submission Details

510(k) Number K850454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1985
Decision Date March 01, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 261
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K850454.
CARDIOSTAT 3 RECORDER
K851044 · Siemens Elema AB · Jun 1985
CARDIOSTAT 1 ECG RECORDER
K844392 · Siemens Elema AB · Apr 1985
MONITORING SYSTEM M720
K842944 · Burdick Corp. · Mar 1985
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985
ELECTROCARDIOGRAPH E-340
K840440 · Burdick Corp. · Aug 1984
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984