Cleared Traditional

K884009 - MODEL 459 ELECTROCARDIOCORDER RECORDER

K884009 is the FDA 510(k) clearance for MODEL 459 ELECTROCARDIOCORDER RECORDER by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K884009 · Del Mar Avionics · Cardiovascular device
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Nov 1988
Decision
49d
Days
Class 2
Risk

K884009 is an FDA 510(k) clearance for the MODEL 459 ELECTROCARDIOCORDER RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on November 9, 1988 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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

Submission Details

510(k) Number K884009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1988
Decision Date November 09, 1988
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 73
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K884009.
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
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K870578 · Buckman Co., Inc. · Jun 1987