Cleared Traditional

K032363 - ZOLL M SERIES NIBP OPTION

K032363 is the FDA 510(k) clearance for ZOLL M SERIES NIBP OPTION by Zoll Medical Corp. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K032363 · Zoll Medical Corp · Cardiovascular device
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Oct 2003
Decision
92d
Days
Class 2
Risk

K032363 is an FDA 510(k) clearance for the ZOLL M SERIES NIBP OPTION. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Zoll Medical Corp (Chelsmford, US). The FDA issued a Cleared decision on October 31, 2003 after a review of 92 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 Zoll Medical Corp devices

Submission Details

510(k) Number K032363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2003
Decision Date October 31, 2003
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 469
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