Cleared Traditional

K860196 - OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901

K860196 is an FDA 510(k) clearance for OSCILLOMATE NEONATAL BLOOD PRESS. MONIT..., manufactured by Cas Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K860196 · Cas Medical Systems, Inc. · Cardiovascular device
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May 1986
Decision
110d
Days
Class 2
Risk

K860196 is an FDA 510(k) clearance for the OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901. 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 May 12, 1986 after a review of 110 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K860196

510(k) Number K860196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date May 12, 1986
Days to Decision 110 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 125d · This submission: 110d
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 844
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K860196.
LIFESTAT 100
K853561 · Physio-Control Corp. · Jun 1986
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K854942 · Mennen Medical, Inc. · Jun 1986
DINAMAP VITAL SIGNS MONITOR MODEL 8100
K854434 · Critikon Company, LLC · May 1986
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K854370 · Nihon Kohden America, Inc. · Apr 1986
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K852574 · Welch Allyn, Inc. · Mar 1986
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K844252 · Medtronic Vascular · Jun 1985