Cleared Traditional

K833661 - ELECTROCARDIOCORDER RECORDER 453

K833661 is the FDA 510(k) clearance for ELECTROCARDIOCORDER RECORDER 453 by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K833661 · Del Mar Avionics · Cardiovascular device
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Nov 1983
Decision
41d
Days
Class 2
Risk

K833661 is an FDA 510(k) clearance for the ELECTROCARDIOCORDER RECORDER 453. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Del Mar Avionics (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 41 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 K833661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date November 28, 1983
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 K833661.
SPACELABS MODEL 90201 HOLTER RECORDER
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DEL MAR AVIONICS 509 NEUROCORDER AMBUL
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MINGOGRAF 7
K841868 · Siemens Medical Solutions USA, Inc. · Oct 1984
OMAR
K830915 · Oxford Medilog, Inc. · Jul 1983
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · Marquette Electronics, Inc. · Dec 1982
CASSETTE READER
K811253 · American Edwards Laboratories · Jul 1981