Cleared Traditional

K863652 - MODEL 456 ELECTROCARDIORECORDER RECORDER

K863652 is an FDA 510(k) clearance for MODEL 456 ELECTROCARDIORECORDER RECORDER, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K863652 · Del Mar Avionics · Cardiovascular device
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Dec 1986
Decision
83d
Days
Class 2
Risk

K863652 is an FDA 510(k) clearance for the MODEL 456 ELECTROCARDIORECORDER RECORDER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on December 10, 1986 after a review of 83 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 Del Mar Avionics devices

FDA 510(k) Submission Details - K863652

510(k) Number K863652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date December 10, 1986
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 406
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K863652.
MINGOGRAF 410
K864009 · Siemens Medical Solutions USA, Inc. · Jan 1987
LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.
K863535 · Computerized Medical Systems, Inc. · Jan 1987
MODIFICATION TO DYNASCOPE SERIES MONITORS
K863914 · Fukuda Denshi USA, Inc. · Jan 1987
630C ELECTROCARDIOGRAPH
K863030 · Quinton, Inc. · Nov 1986
ECG MODULE
K862553 · Elscint, Inc. · Nov 1986
SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR
K860734 · Marquette Electronics, Inc. · Nov 1986