Cleared Traditional

K810176 - ECG FUNCTION BLOCK

K810176 is an FDA 510(k) clearance for ECG FUNCTION BLOCK, 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 34-day FDA review.

K810176 · Honeywell, Inc. · Cardiovascular device
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Feb 1981
Decision
34d
Days
Class 2
Risk

K810176 is an FDA 510(k) clearance for the ECG FUNCTION BLOCK. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 25, 1981 after a review of 34 days - a notably fast clearance 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: 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 - K810176

510(k) Number K810176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1981
Decision Date February 25, 1981
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 K810176.
LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM
K810154 · Physio-Control Corp. · Mar 1981
STRESS TEST SYSTEM
K810357 · Nihon Kohden America, Inc. · Mar 1981
OPTION 301 PACEMAKER EVAL. MODULE MAC-1
K802368 · Marquette Electronics, Inc. · Mar 1981
MICROPROCESSOR CONTROLLED ELECTROCARDIO
K810263 · Honeywell, Inc. · Feb 1981
SIRECUST 400 SYSTEM PATIENT MONITORING
K802113 · Analogic Corp. · Jan 1981
VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH
K803309 · Advanced Technology Laboratories, Inc. · Jan 1981