Cleared Traditional

K897173 - SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR

K897173 is an FDA 510(k) clearance for SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE..., manufactured by Advanced Medical Instruments, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K897173

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.

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 912
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K897173.
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K901889 · Fukuda Denshi USA, Inc. · Jul 1990
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