Cleared Traditional

K860024 - FUKUDA DENSHI CARDIMAX FCP-211

K860024 is an FDA 510(k) clearance for FUKUDA DENSHI CARDIMAX FCP-211, manufactured by Brentwood Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K860024 · Brentwood Instruments, Inc. · Cardiovascular device
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Mar 1986
Decision
87d
Days
Class 2
Risk

K860024 is an FDA 510(k) clearance for the FUKUDA DENSHI CARDIMAX FCP-211. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Torrange, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 87 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 Brentwood Instruments, Inc. devices

FDA 510(k) Submission Details - K860024

510(k) Number K860024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1986
Decision Date March 31, 1986
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 270
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K860024.
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
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SPACELABS MEDICAL WORKSTATION
K860834 · Spacelabs, Inc. · Apr 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669 · Hewlett-Packard Co. · Mar 1986
MEDILOG 2500 SYSTEM
K860078 · Oxford Medilog, Inc. · Feb 1986
MEDILOG 4500 SYSTEM
K860079 · Oxford Medilog, Inc. · Feb 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · Fukuda Denshi USA, Inc. · Feb 1986