Cleared Traditional

K811581 - ARRHYTHMIA FUNCTION BLOCK

K811581 is an FDA 510(k) clearance for ARRHYTHMIA FUNCTION BLOCK, manufactured by Honeywell, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K811581 · Honeywell, Inc. · Cardiovascular device
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Aug 1981
Decision
69d
Days
Class 2
Risk

K811581 is an FDA 510(k) clearance for the ARRHYTHMIA FUNCTION BLOCK. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 69 days - a notably fast clearance 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: 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 - K811581

510(k) Number K811581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1981
Decision Date August 13, 1981
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 238
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K811581.
QUINTON Q2000 ETT MONITORING SYSTEM
K820438 · Quinton, Inc. · Apr 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · Hewlett-Packard Co. · Apr 1982
MICRO-PREPROCESSOR UNIT
K812914 · General Electric Co. · Dec 1981
THE BETA
K810940 · Burdick Corp. · Jul 1981
ARRYTHMIA PRINTER OPTION
K811792 · American Edwards Laboratories · Jul 1981
DEL MAR AVIONICS MODELS 9400 & 9401
K811122 · Del Mar Avionics · Jun 1981