Cleared Traditional

K895806 - ELATEC HOLTER ANALYZER

K895806 is an FDA 510(k) clearance for ELATEC HOLTER ANALYZER, manufactured by Ela Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K895806 · Ela Medical, Inc. · Cardiovascular device
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Apr 1990
Decision
188d
Days
Class 2
Risk

K895806 is an FDA 510(k) clearance for the ELATEC HOLTER ANALYZER. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 188 days - an extended review 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: 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 Ela Medical, Inc. devices

FDA 510(k) Submission Details - K895806

510(k) Number K895806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1989
Decision Date April 04, 1990
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 301
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K895806.
TRAM PATIENT MONITOR
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CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
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MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM
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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
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
K894628 · Fukuda Denshi USA, Inc. · Jan 1990