Cleared Traditional

K963174 - HOLTER DIGICORDER WITH PACER OPTION (MO...

K963174 is the FDA 510(k) clearance for HOLTER DIGICORDER WITH PACER OPTION (MO... by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K963174 · Del Mar Avionics · Cardiovascular device
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Mar 1997
Decision
211d
Days
Class 2
Risk

K963174 is an FDA 510(k) clearance for the HOLTER DIGICORDER WITH PACER OPTION (MODEL 483). 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 March 13, 1997 after a review of 211 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.

View all Del Mar Avionics devices

Submission Details

510(k) Number K963174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date March 13, 1997
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
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
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