Cleared Traditional

K840622 - CARDIO EXPRESS 100 HOLTER SCANNER

K840622 is the FDA 510(k) clearance for CARDIO EXPRESS 100 HOLTER SCANNER by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K840622 · Del Mar Avionics · Cardiovascular device
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Jul 1984
Decision
139d
Days
Class 2
Risk

K840622 is an FDA 510(k) clearance for the CARDIO EXPRESS 100 HOLTER SCANNER. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Del Mar Avionics (Walker, US). The FDA issued a Cleared decision on July 2, 1984 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Del Mar Avionics devices

Submission Details

510(k) Number K840622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1984
Decision Date July 02, 1984
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 225
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K840622.
ARRHYTHMIA CENTRAL OCC-7101
K843287 · Nihon Kohden America, Inc. · Oct 1984
SPACELABS ICR ARRHYTHMIA MASTER I HOLTER
K842640 · Spacelabs, Inc. · Oct 1984
LIFESCOPE 6 OEC-6201
K841500 · Nihon Kohden America, Inc. · Aug 1984
LEAP FROG
K834211 · Philips Medical Systems (Cleveland), Inc. · Jun 1984
ALPHA MASS STORAGE CARDULE 1895
K834597 · Spacelabs, Inc. · Apr 1984
AMBULATORY MONITORING DEVICE
K833162 · Oxford Medilog, Inc. · Jan 1984