Cleared Traditional

K860950 - SCM-400 HOLTER SYSTEM

K860950 is the FDA 510(k) clearance for SCM-400 HOLTER SYSTEM 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.

K860950 · Fukuda Denshi USA, Inc. · Cardiovascular device
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May 1986
Decision
51d
Days
Class 2
Risk

K860950 is an FDA 510(k) clearance for the SCM-400 HOLTER SYSTEM. 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 May 2, 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 K860950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1986
Decision Date May 02, 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 K860950.
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
K863159 · Quinton, Inc. · Oct 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980 · Spacelabs, Inc. · May 1986
595 ARRHYTHMIA MONITORING SYSTEM
K852250 · Burdick Corp. · May 1986
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
K860470 · Del Mar Avionics · Apr 1986
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
K860471 · Del Mar Avionics · Apr 1986
SPACELABS MEDICAL WORKSTATION
K860834 · Spacelabs, Inc. · Apr 1986