Cleared Traditional

K872508 - MODEL MICRO FD+ AMBULATORY ECG MONITOR

K872508 is an FDA 510(k) clearance for MODEL MICRO FD+ AMBULATORY ECG MONITOR, manufactured by Advanced Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K872508 · Advanced Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
93d
Days
Class 2
Risk

K872508 is an FDA 510(k) clearance for the MODEL MICRO FD+ AMBULATORY ECG MONITOR. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Advanced Medical Products, Inc. (E. Syracuse, US). The FDA issued a Cleared decision on September 25, 1987 after a review of 93 days - within the typical 510(k) review window.

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: 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 Advanced Medical Products, Inc. devices

FDA 510(k) Submission Details - K872508

510(k) Number K872508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1987
Decision Date September 25, 1987
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K872508.
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330 · Del Mar Avionics · Jan 1989
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009 · Del Mar Avionics · Nov 1988
MODEL 492 SSR (TM) RECORDER
K874313 · Del Mar Avionics · Feb 1988
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246 · Medtronic Vascular · Jul 1987
NIGHTWATCH(TM) SYSTEM
K870578 · Buckman Co., Inc. · Jun 1987
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER
K854269 · Del Mar Avionics · Apr 1986