Cleared Traditional

K942543 - ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS

K942543 is an FDA 510(k) clearance for ANEROID SPHYGMOMANOMETERS/MERCURIAL SPH..., manufactured by Sankei Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K942543 · Sankei Co., Ltd. · Cardiovascular device
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Jul 1995
Decision
445d
Days
Class 2
Risk

K942543 is an FDA 510(k) clearance for the ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Sankei Co., Ltd. (Inverness, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 445 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.

View all Sankei Co., Ltd. devices

FDA 510(k) Submission Details - K942543

510(k) Number K942543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1994
Decision Date July 14, 1995
Days to Decision 445 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
320d slower than avg
Panel avg: 125d · This submission: 445d
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 911
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