Cleared Traditional

K810163 - AM 420 MICROPROCESSOR

K810163 is an FDA 510(k) clearance for AM 420 MICROPROCESSOR, manufactured by Honeywell, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K810163 · Honeywell, Inc. · Cardiovascular device
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Mar 1981
Decision
42d
Days
Class 2
Risk

K810163 is an FDA 510(k) clearance for the AM 420 MICROPROCESSOR. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Honeywell, Inc. (Walker, US). The FDA issued a Cleared decision on March 5, 1981 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K810163

510(k) Number K810163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1981
Decision Date March 05, 1981
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 85
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K810163.
SORENSON THERMODILUTION CARDIAC COMPUT
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BAIM CORONARY SINUS FLOW ANALYZER
K811414 · Electro-Catheter Corp. · Jun 1981
TREND GRAPH FUNCTION BLOCK
K810170 · Honeywell, Inc. · Feb 1981
PATIENT MONITOR MODEL CM130, 140
K810177 · Honeywell, Inc. · Feb 1981
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K802316 · General Electric Co. · Nov 1980