Cleared Traditional

K964697 - AMD HOME HEALTH MONITOR SYSTEM AND AMD ...

K964697 is an FDA 510(k) clearance for AMD HOME HEALTH MONITOR SYSTEM AND AMD ..., manufactured by Advance Medical Device, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K964697 · Advance Medical Device, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K964697

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.

DXN Device Classification - Class 2, Special Controls

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 592
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