Cleared Traditional

K872497 - MODEL MR-45 AMBULATORY HOLTER MONITOR

K872497 is an FDA 510(k) clearance for MODEL MR-45 AMBULATORY HOLTER MONITOR, 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 104-day FDA review.

K872497 · Oxford Medilog, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
104d
Days
Class 2
Risk

K872497 is an FDA 510(k) clearance for the MODEL MR-45 AMBULATORY HOLTER MONITOR. 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 October 6, 1987 after a review of 104 days - within the typical 510(k) review window.

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 Medilog, Inc. devices

FDA 510(k) Submission Details - K872497

510(k) Number K872497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1987
Decision Date October 06, 1987
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 K872497.
CARDIOFAX-V ECG-8110A
K873874 · Nihon Kohden America, Inc. · Jan 1988
FUKUDA DENSHI MODEL FCP-231
K874768 · Fukuda Denshi USA, Inc. · Dec 1987
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680 · Oxford Medilog, Inc. · Nov 1987
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · Nihon Kohden America, Inc. · Sep 1987
FUKUDA DENSHI MODEL FCP-15
K871025 · Fukuda Denshi USA, Inc. · Mar 1987
CARDIOFAX-V ECG-8240A
K865030 · Nihon Kohden America, Inc. · Mar 1987