Cleared Traditional

K861364 - NEOGUARD ECG ELECTRODES

K861364 is an FDA 510(k) clearance for NEOGUARD ECG ELECTRODES, 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 117-day FDA review.

K861364 · Cas Medical Systems, Inc. · Cardiovascular device
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Aug 1986
Decision
117d
Days
Class 2
Risk

K861364 is an FDA 510(k) clearance for the NEOGUARD ECG ELECTRODES. 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 August 6, 1986 after a review of 117 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 - K861364

510(k) Number K861364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1986
Decision Date August 06, 1986
Days to Decision 117 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
8d faster than avg
Panel avg: 125d · This submission: 117d
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 K861364.
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915
K860488 · Cas Medical Systems, Inc. · Aug 1986
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
K861504 · Fukuda Denshi USA, Inc. · Aug 1986
AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202
K855127 · Spacelabs, Inc. · Aug 1986
PREGELLED INFANT DISPOSABLE ECG ELECTRODE
K862756 · Labeltape Meditect, Inc. · Aug 1986
LIFESTAT 100
K853561 · Physio-Control Corp. · Jun 1986
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
K854942 · Mennen Medical, Inc. · Jun 1986