Cleared Traditional

MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL (K853669) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853669 · Hewlett-Packard Co. · Cardiovascular device
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Mar 1986
Decision
209d
Days
Class 2
Risk

K853669 is an FDA 510(k) clearance for the MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mcminnville, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 209 days - an extended review 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: 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K853669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date March 31, 1986
Days to Decision 209 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
84d slower than avg
Panel avg: 125d · This submission: 209d
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 93
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K853669.
CARDIOFAX-V ECG-834OA
K865032 · Nihon Kohden America, Inc. · Mar 1987
Q-SCAN II AND Q-SCAN III
K864149 · Quinton, Inc. · Dec 1986
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
K863159 · Quinton, Inc. · Oct 1986
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · Hewlett-Packard Co. · Sep 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270 · Nihon Kohden America, Inc. · Jul 1985
HORIZON ECG SYSTEM
K823844 · Beckman Instruments, Inc. · Jan 1985