Cleared Traditional

K855094 - FUKUDA DENSHI ALTHUS 5100 PATIENT MONIT...

K855094 is the FDA 510(k) clearance for FUKUDA DENSHI ALTHUS 5100 PATIENT MONIT... by Fukuda Denshi USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K855094 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Feb 1986
Decision
51d
Days
Class 2
Risk

K855094 is an FDA 510(k) clearance for the FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Kirkland, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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.

View all Fukuda Denshi USA, Inc. devices

Submission Details

510(k) Number K855094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date February 12, 1986
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 231
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K855094.
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
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MEDILOG 2500 SYSTEM
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MEDILOG 4500 SYSTEM
K860079 · Oxford Medilog, Inc. · Feb 1986
MEDILOG M6
K852892 · Oxford Medilog, Inc. · Dec 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352 · Fukuda Denshi USA, Inc. · Nov 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213 · Fukuda Denshi USA, Inc. · Oct 1985