Cleared Traditional

K840440 - ELECTROCARDIOGRAPH E-340

K840440 is an FDA 510(k) clearance for ELECTROCARDIOGRAPH E-340, 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 184-day FDA review.

K840440 · Burdick Corp. · Cardiovascular device
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Aug 1984
Decision
184d
Days
Class 2
Risk

K840440 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH E-340. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Burdick Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1984 after a review of 184 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 - K840440

510(k) Number K840440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date August 03, 1984
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K840440.
CARDIO-NEC MODEL 365
K844101 · Birtcher Corp. · Apr 1985
MONITORING SYSTEM M720
K842944 · Burdick Corp. · Mar 1985
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984
E 310 ELECTROCARDIOGRAPH
K833951 · Burdick Corp. · May 1984
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984