Cleared Traditional

K923344 - ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR

K923344 is an FDA 510(k) clearance for ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR, manufactured by Citizen Watch Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 476-day FDA review.

K923344 · Citizen Watch Co., Ltd. · Cardiovascular device
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Oct 1993
Decision
476d
Days
Class 2
Risk

K923344 is an FDA 510(k) clearance for the ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Citizen Watch Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K923344

510(k) Number K923344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date October 07, 1993
Days to Decision 476 days
Submission Type Traditional
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
351d slower than avg
Panel avg: 125d · This submission: 476d
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 1215
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K923344.
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K935872 · Nam Tai Electronics (Canada) , Ltd. · Jan 1994
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K935652 · Nam Tai Electronics (Canada) , Ltd. · Dec 1993
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OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300
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K915697 · Critikon Company, LLC · Jul 1993
BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST
K921048 · Colin Medical Instruments Corp. · Jul 1993
K923344 · ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR
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