Cleared Traditional

HOLTER ECG SCANNER (K820014) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K820014 · Laser Scan Corp. · Cardiovascular device
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Apr 1982
Decision
106d
Days
Class 2
Risk

K820014 is an FDA 510(k) clearance for the HOLTER ECG SCANNER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Laser Scan Corp. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982 after a review of 106 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 Laser Scan Corp. devices

Submission Details

510(k) Number K820014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1982
Decision Date April 21, 1982
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
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 123
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K820014.
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · Nihon Kohden America, Inc. · Dec 1982
COSMOS
K823220 · Nihon Kohden America, Inc. · Nov 1982
QUINTON Q, SCAN MODELS 900 & 901
K821758 · Quinton, Inc. · Aug 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · Nihon Kohden America, Inc. · Feb 1982
ELECTROCARDIOGRAPH CM3000
K813279 · Philips Medical Systems (Cleveland), Inc. · Dec 1981
STRESS TEST SYSTEM
K810357 · Nihon Kohden America, Inc. · Mar 1981