Cleared Traditional

K896862 - MODEL 263 SPECTRASCAN(TM) HOLTER ANALYS...

K896862 is the FDA 510(k) clearance for MODEL 263 SPECTRASCAN(TM) HOLTER ANALYS... by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K896862 · Del Mar Avionics · Cardiovascular device
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Apr 1990
Decision
133d
Days
Class 2
Risk

K896862 is an FDA 510(k) clearance for the MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on April 18, 1990 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 K896862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1989
Decision Date April 18, 1990
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 225
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K896862.
MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
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TRAM PATIENT MONITOR
K900540 · Marquette Electronics, Inc. · Jul 1990
ELATEC HOLTER ANALYZER
K895806 · Ela Medical, Inc. · Apr 1990
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
K894543 · Del Mar Avionics · Feb 1990
FUKUDA DENSHI MODEL DS-3300 ETR
K897063 · Fukuda Denshi USA, Inc. · Feb 1990