Cleared Traditional

K892835 - E350 ELECTROCARDIOGRAPH

K892835 is an FDA 510(k) clearance for E350 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 44-day FDA review.

K892835 · Burdick Corp. · Cardiovascular device
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Jun 1989
Decision
44d
Days
Class 2
Risk

K892835 is an FDA 510(k) clearance for the E350 ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Burdick Corp. (Miltoon, US). The FDA issued a Cleared decision on June 1, 1989 after a review of 44 days - a notably fast clearance 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: 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 Burdick Corp. devices

FDA 510(k) Submission Details - K892835

510(k) Number K892835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date June 01, 1989
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
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 275
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K892835.
MINIMON 7133B PATIENT MONITOR
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ECG SIMULATOR MODEL ECGPLUS
K893660 · Bio-Tek Instruments, Inc. · Dec 1989
TYPE 9040 SYSTEM ATHENA
K884116 · S & W Medico Teknik · Apr 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989
PATIENT MONITOR MODEL 703
K884662 · Ivy Biomedical Systems, Inc. · Feb 1989