Cleared Traditional

K923595 - SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR

K923595 is an FDA 510(k) clearance for SYSTEM 7110 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 346-day FDA review.

K923595 · Advanced Medical Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
346d
Days
Class 2
Risk

K923595 is an FDA 510(k) clearance for the SYSTEM 7110 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 July 1, 1993 after a review of 346 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. Elevated predicate reliance profile. 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 - K923595

510(k) Number K923595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date July 01, 1993
Days to Decision 346 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
221d slower than avg
Panel avg: 125d · This submission: 346d
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 K923595.
BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK
K932823 · Portable Power Systems, Inc. · Feb 1994
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300
K925402 · Cas Medical Systems, Inc. · Sep 1993
CRITIKON VITAL SIGNS MODULE
K915697 · Critikon Company, LLC · Jul 1993
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
K930798 · Omron Healthcare, Inc. · May 1993
OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601
K920778 · Omron Healthcare, Inc. · Dec 1992
OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
K914823 · Omron Healthcare, Inc. · Dec 1992