Cleared Traditional

MEDILOG EXCEL ECG ANALYSIS SYSTEM (K885256) - FDA 510(k) Clearance

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

K885256 · Oxford Medical, Inc. · Cardiovascular device
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May 1989
Decision
159d
Days
Class 2
Risk

K885256 is an FDA 510(k) clearance for the MEDILOG EXCEL ECG ANALYSIS SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Oxford Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on May 31, 1989 after a review of 159 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 Oxford Medical, Inc. devices

Submission Details

510(k) Number K885256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date May 31, 1989
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 125d · This submission: 159d
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 94
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K885256.
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
CARDIOFAX-V ECG-8110A
K873874 · Nihon Kohden America, Inc. · Jan 1988