Cleared Traditional

K820014 - HOLTER ECG SCANNER

K820014 is an FDA 510(k) clearance for HOLTER ECG SCANNER, manufactured by Laser Scan Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K820014

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.

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 463
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K820014.
COSMOS
K823220 · Nihon Kohden America, Inc. · Nov 1982
QUINTON Q, SCAN MODELS 900 & 901
K821758 · Quinton, Inc. · Aug 1982
AUTOMATIC SINGLE CHANNEL ECG #399
K821888 · Birtcher Corp. · Jul 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · Nihon Kohden America, Inc. · Feb 1982
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36
K813021 · Brentwood Instruments, Inc. · Dec 1981
ELECTROCARDIOGRAPH CM3000
K813279 · Philips Medical Systems (Cleveland), Inc. · Dec 1981