Cleared Special

K043018 - OMRON DIGITAL BLOOD PRESSURE MONITOR

K043018 is the FDA 510(k) clearance for OMRON DIGITAL BLOOD PRESSURE MONITOR by Omron Healthcare, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 8-day FDA review.

K043018 · Omron Healthcare, Inc. · Cardiovascular device
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Nov 2004
Decision
8d
Days
Class 2
Risk

K043018 is an FDA 510(k) clearance for the OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on November 10, 2004 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omron Healthcare, Inc. devices

Submission Details

510(k) Number K043018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2004
Decision Date November 10, 2004
Days to Decision 8 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 125d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K043018.
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
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K043186 · Health & Life Co., Ltd. · Dec 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA
K042853 · Health & Life Co., Ltd. · Nov 2004
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q
K042802 · Health & Life Co., Ltd. · Oct 2004
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