Cleared Traditional

K861504 - MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR

K861504 is an FDA 510(k) clearance for MODEL FB-20 NON-INVASIVE BLOOD PRESSURE..., manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K861504 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Aug 1986
Decision
124d
Days
Class 2
Risk

K861504 is an FDA 510(k) clearance for the MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Kirkland, US). The FDA issued a Cleared decision on August 25, 1986 after a review of 124 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Fukuda Denshi USA, Inc. devices

FDA 510(k) Submission Details - K861504

510(k) Number K861504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1986
Decision Date August 25, 1986
Days to Decision 124 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 125d · This submission: 124d
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 893
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K861504.
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