Cleared Traditional

K863724 - MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM

K863724 is an FDA 510(k) clearance for MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM, manufactured by Oxford Medilog, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K863724 · Oxford Medilog, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
58d
Days
Class 2
Risk

K863724 is an FDA 510(k) clearance for the MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on November 20, 1986 after a review of 58 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 Oxford Medilog, Inc. devices

FDA 510(k) Submission Details - K863724

510(k) Number K863724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date November 20, 1986
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 234
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K863724.
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
K864506 · Spacelabs, Inc. · Nov 1986
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
K864505 · Spacelabs, Inc. · Nov 1986
CASE 12
K862316 · Marquette Electronics, Inc. · Nov 1986
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
K863159 · Quinton, Inc. · Oct 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980 · Spacelabs, Inc. · May 1986
595 ARRHYTHMIA MONITORING SYSTEM
K852250 · Burdick Corp. · May 1986