Cleared Traditional

K810940 - THE BETA

K810940 is an FDA 510(k) clearance for THE BETA, manufactured by Burdick Corp.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K810940 · Burdick Corp. · Cardiovascular device
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Jul 1981
Decision
100d
Days
Class 2
Risk

K810940 is an FDA 510(k) clearance for the THE BETA. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Burdick Corp. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 100 days - within the typical 510(k) review window.

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: 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 Burdick Corp. devices

FDA 510(k) Submission Details - K810940

510(k) Number K810940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1981
Decision Date July 16, 1981
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
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 K810940.
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · Hewlett-Packard Co. · Apr 1982
MICRO-PREPROCESSOR UNIT
K812914 · General Electric Co. · Dec 1981
ARRHYTHMIA FUNCTION BLOCK
K811581 · Honeywell, Inc. · Aug 1981
ARRYTHMIA PRINTER OPTION
K811792 · American Edwards Laboratories · Jul 1981
DEL MAR AVIONICS MODELS 9400 & 9401
K811122 · Del Mar Avionics · Jun 1981
SIRECUST 358
K803208 · Siemens Corp. · May 1981