Cleared Traditional

K833951 - E 310 ELECTROCARDIOGRAPH

K833951 is an FDA 510(k) clearance for E 310 ELECTROCARDIOGRAPH, manufactured by Burdick Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 176-day FDA review.

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

FDA 510(k) Submission Details - K833951

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
Combination Product No
PCCP Authorized No
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.

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 277
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K833951.
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985
ELECTROCARDIOGRAPH E-340
K840440 · Burdick Corp. · Aug 1984
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984
MORTARA INSTRUMENT #101
K832050 · Mortara Instrument, Inc. · Dec 1983
CASE-II
K833458 · Marquette Electronics, Inc. · Nov 1983