Cleared Traditional

E 310 ELECTROCARDIOGRAPH (K833951) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833951 · Burdick Corp. · Cardiovascular device
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May 1984
Decision
176d
Days
Class 2
Risk

K833951 is an FDA 510(k) clearance for the E 310 ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Burdick Corp. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 176 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 Burdick Corp. devices

Submission Details

510(k) Number K833951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1983
Decision Date May 09, 1984
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 122
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K833951.
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · Hewlett-Packard Co. · May 1986
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984
MODEL RM 6000, 6100,6200 POLYGRAPH
K823281 · Nihon Kohden America, Inc. · Dec 1982
COSMOS
K823220 · Nihon Kohden America, Inc. · Nov 1982
QUINTON Q, SCAN MODELS 900 & 901
K821758 · Quinton, Inc. · Aug 1982