Cleared Traditional

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION (K964697) - FDA 510(k) Clearance

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

K964697 · Advance Medical Device, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
81d
Days
Class 2
Risk

K964697 is an FDA 510(k) clearance for the AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Advance Medical Device, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 11, 1997 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Advance Medical Device, Inc. devices

Submission Details

510(k) Number K964697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1996
Decision Date February 11, 1997
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 246
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K964697.
Fully Automatic Electronic Blood Pressure Monitor
K162668 · Andon Health Co, Ltd. · Feb 2017
Fully Automatic Electronic Blood Pressure Monitor
K162915 · Andon Health Co, Ltd. · Feb 2017
iHealth Wireless Blood Pressure Monitor
K162144 · Andon Health Co, Ltd. · Feb 2017
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
K903771 · Hewlett-Packard Co. · Feb 1991
AP-851PA NIBP MODULE
K894693 · Nihon Kohden America, Inc. · Oct 1989
POCKET MANOMETER
K880599 · Abbott Laboratories · Oct 1988