Cleared Traditional

K911722 - OSCILLOMATE (TM) BLOOD PRESSURE MONITOR...

K911722 is the FDA 510(k) clearance for OSCILLOMATE (TM) BLOOD PRESSURE MONITOR... by Cas Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K911722 · Cas Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
280d
Days
Class 2
Risk

K911722 is an FDA 510(k) clearance for the OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on January 22, 1992 after a review of 280 days - an extended review 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: 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 Cas Medical Systems, Inc. devices

Submission Details

510(k) Number K911722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date January 22, 1992
Days to Decision 280 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 125d · This submission: 280d
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 501
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K911722.
NIBP 9225 COMBI
K912815 · S & W Medico Teknik · Oct 1992
BP PUMP
K921074 · Bio-Tek Instruments, Inc. · Oct 1992
NGM NIBP MODULE
K911645 · Datex Division Instrumentarium Corp. · Mar 1992
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
K913523 · Omron Healthcare, Inc. · Nov 1991
CARDIOCAP CMX-104 MONITOR
K903237 · Datex Division Instrumentarium Corp. · Jul 1991
COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD
K911310 · Ge Medical Systems Information Technologies · Jun 1991