Cleared Traditional

K984083 - MULTIFUNCTION KEITO K5

K984083 is the FDA 510(k) clearance for MULTIFUNCTION KEITO K5 by Bumedco Intl., Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K984083 · Bumedco Intl., Inc. · Cardiovascular device
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Jan 2000
Decision
428d
Days
Class 2
Risk

K984083 is an FDA 510(k) clearance for the MULTIFUNCTION KEITO K5. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Bumedco Intl., Inc. (Shoreview, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 428 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 Bumedco Intl., Inc. devices

Submission Details

510(k) Number K984083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date January 18, 2000
Days to Decision 428 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
303d slower than avg
Panel avg: 125d · This submission: 428d
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 520
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