Cleared Traditional

K860078 - MEDILOG 2500 SYSTEM

K860078 is an FDA 510(k) clearance for MEDILOG 2500 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 49-day FDA review.

K860078 · Oxford Medilog, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
49d
Days
Class 2
Risk

K860078 is an FDA 510(k) clearance for the MEDILOG 2500 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 February 26, 1986 after a review of 49 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 - K860078

510(k) Number K860078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1986
Decision Date February 26, 1986
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 K860078.
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
K860471 · Del Mar Avionics · Apr 1986
SPACELABS MEDICAL WORKSTATION
K860834 · Spacelabs, Inc. · Apr 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669 · Hewlett-Packard Co. · Mar 1986
MEDILOG 4500 SYSTEM
K860079 · Oxford Medilog, Inc. · Feb 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · Fukuda Denshi USA, Inc. · Feb 1986
MEDILOG M6
K852892 · Oxford Medilog, Inc. · Dec 1985