Cleared Traditional

K874571 - PATIENTWATCH (TM)

K874571 is the FDA 510(k) clearance for PATIENTWATCH (TM) by Advanced Medical Technology, Inc.. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K874571 · Advanced Medical Technology, Inc. · Cardiovascular device
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Jan 1988
Decision
85d
Days
Class 2
Risk

K874571 is an FDA 510(k) clearance for the PATIENTWATCH (TM). Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Advanced Medical Technology, Inc. (Martinez, US). The FDA issued a Cleared decision on January 29, 1988 after a review of 85 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 Advanced Medical Technology, Inc. devices

Submission Details

510(k) Number K874571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1987
Decision Date January 29, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
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 74
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K874571.
MODEL 463 ELECTROCARDIORECORDER RECORDER
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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