Cleared Traditional

K897173 - SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE...

K897173 is the FDA 510(k) clearance for SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE... by Advanced Medical Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K897173 · Advanced Medical Instruments, Inc. · Cardiovascular device
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Oct 1990
Decision
300d
Days
Class 2
Risk

K897173 is an FDA 510(k) clearance for the SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Advanced Medical Instruments, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on October 23, 1990 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Instruments, Inc. devices

Submission Details

510(k) Number K897173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date October 23, 1990
Days to Decision 300 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 125d · This submission: 300d
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 356
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