Cleared Traditional

CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR (K863100) - FDA 510(k) Clearance

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

K863100 · Honeywell, Inc. · Cardiovascular device
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Feb 1987
Decision
174d
Days
Class 2
Risk

K863100 is an FDA 510(k) clearance for the CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Honeywell, Inc. (Pleasantville, US). The FDA issued a Cleared decision on February 3, 1987 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Honeywell, Inc. devices

Submission Details

510(k) Number K863100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date February 03, 1987
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 122
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K863100.
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03
K870380 · Hewlett-Packard Co. · Mar 1987
Q700 ELECTROCARDIOGRAPH
K864700 · Quinton, Inc. · Feb 1987
ELECTROCARDIOGRAPH
K865031 · Nihon Kohden America, Inc. · Feb 1987
MINGOGRAF 410
K864009 · Siemens Medical Solutions USA, Inc. · Jan 1987
630C ELECTROCARDIOGRAPH
K863030 · Quinton, Inc. · Nov 1986
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
K863116 · Nihon Kohden America, Inc. · Sep 1986