Cleared Special

K984223 - BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471

K984223 is an FDA 510(k) clearance for BLOOD PRESSURE METER, manufactured by Citizen Watch Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 154-day FDA review.

K984223 · Citizen Watch Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
154d
Days
Class 2
Risk

K984223 is an FDA 510(k) clearance for the BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Citizen Watch Co., Ltd. (Washington, US). The FDA issued a Cleared decision on April 28, 1999 after a review of 154 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K984223

510(k) Number K984223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1998
Decision Date April 28, 1999
Days to Decision 154 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Modification to existing cleared device.

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 1213
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K984223.
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AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300
K981702 · Nihon Seimitsu Sokki Co., Ltd. · Mar 1999
K984223 · BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
Download PDF FDA Summary Citizen Watch Co., Lt…