Cleared Traditional

K863100 - CEN STA MON AC/DC ALARM CENTRAL ACCES A...

K863100 is an FDA 510(k) clearance for CEN STA MON AC/DC ALARM CENTRAL ACCES A..., manufactured by Honeywell, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 174-day FDA review.

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

FDA 510(k) Submission Details - K863100

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
Combination Product No
PCCP Authorized No
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.

DPS Device Classification - Class 2, Special Controls

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 275
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K863100.
MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM)
K864580 · Mortara Instrument, Inc. · Feb 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
MODIFICATION TO DYNASCOPE SERIES MONITORS
K863914 · Fukuda Denshi USA, Inc. · Jan 1987
MODEL 456 ELECTROCARDIORECORDER RECORDER
K863652 · Del Mar Avionics · Dec 1986