Cleared Traditional

K901889 - FUKUDA DENSHI MODEL HJ-310

K901889 is an FDA 510(k) clearance for FUKUDA DENSHI MODEL HJ-310, 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 82-day FDA review.

K901889 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Jul 1990
Decision
82d
Days
Class 2
Risk

K901889 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL HJ-310. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 82 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K901889

510(k) Number K901889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1990
Decision Date July 17, 1990
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
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 1225
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K901889.
BIOCHEM 6100 NON-INVASIVE MONITOR
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K896958 · Medical Data Electronics · Mar 1990
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K894563 · Omron Electronics, Inc. · Mar 1990
AUTO-CUFF(TM)
K896633 · U.S. Medical Corp. · Feb 1990
K901889 · FUKUDA DENSHI MODEL HJ-310
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