Cleared Traditional

K884887 - MODEL 499 SSR ANALYSIS SYSTEM

K884887 is an FDA 510(k) clearance for MODEL 499 SSR ANALYSIS SYSTEM, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K884887 · Del Mar Avionics · Cardiovascular device
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Feb 1989
Decision
76d
Days
Class 2
Risk

K884887 is an FDA 510(k) clearance for the MODEL 499 SSR 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 February 6, 1989 after a review of 76 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K884887

510(k) Number K884887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1988
Decision Date February 06, 1989
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 299
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K884887.
SUPERMON ARRHYTHMIA MODULE 7270
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SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
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E550 ELECTROCARDIOGRAPH
K883440 · Burdick Corp. · Jan 1989
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K880505 · Ppg Industries, Inc. · Dec 1988
Q4000 OPTION FOR Q4000
K882978 · Quinton, Inc. · Nov 1988