Cleared Traditional

K841654 - DEL MAR AVIONICS 509 NEUROCORDER AMBUL

K841654 is an FDA 510(k) clearance for DEL MAR AVIONICS 509 NEUROCORDER AMBUL, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K841654 · Del Mar Avionics · Cardiovascular device
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Dec 1984
Decision
232d
Days
Class 2
Risk

K841654 is an FDA 510(k) clearance for the DEL MAR AVIONICS 509 NEUROCORDER AMBUL. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Del Mar Avionics (Walker, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 232 days - an extended review 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: 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.

FDA 510(k) Submission Details - K841654

510(k) Number K841654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date December 11, 1984
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

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 194
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K841654.
AMBULATORY PH RECORDING DEVICE
K842349 · Clinical Data Instruments, Inc. · Jun 1985
SPACELABS MODEL 90201 HOLTER RECORDER
K844940 · Spacelabs, Inc. · Feb 1985
HOLTER CURA-LITE RECORDER
K844977 · Cardionostics, Inc. · Jan 1985
CARDIORHYTHM 2000
K841472 · Biogenix, Inc. · Oct 1984
MINGOGRAF 7
K841868 · Siemens Medical Solutions USA, Inc. · Oct 1984
CARDIONOSTICS HOLTER DURA-LITE RECORDE
K842954 · Cardionostics, Inc. · Sep 1984
K841654 · DEL MAR AVIONICS 509 NEUROCORDER AMBUL
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