Cleared Traditional

DMI AMBULATORY HOLTER MONITOR (K871045) - FDA 510(k) Clearance

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

K871045 · Diagnostic Medical Instruments · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
63d
Days
Class 2
Risk

K871045 is an FDA 510(k) clearance for the DMI AMBULATORY HOLTER MONITOR. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Diagnostic Medical Instruments (Syracuse, US). The FDA issued a Cleared decision on May 19, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Diagnostic Medical Instruments devices

Submission Details

510(k) Number K871045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1987
Decision Date May 19, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 34
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K871045.
ePatch
K171410 · Braemar Manufacturing, LLC · Jan 2018
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION
K974420 · Hewlett-Packard Co. · Feb 1998
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246 · Medtronic Vascular · Jul 1987
MINGOGRAF 7
K841868 · Siemens Medical Solutions USA, Inc. · Oct 1984