Cleared Traditional

ELATEC HOLTER ANALYZER (K895806) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 91
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K895806.
Q-SMART HOLTER SYSTEMS
K910808 · Quinton, Inc. · Jul 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490 · Hewlett-Packard Co. · Apr 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291 · Hewlett-Packard Co. · Apr 1991
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692 · Nihon Kohden America, Inc. · Oct 1989
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106 · Siemens Medical Solutions USA, Inc. · Mar 1989
Q4000 OPTION FOR Q4000
K882978 · Quinton, Inc. · Nov 1988