Cleared Traditional

K833819 - M305

K833819 is an FDA 510(k) clearance for M305, manufactured by Burkick Corp.. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K833819 · Burkick Corp. · Cardiovascular device
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May 1984
Decision
189d
Days
Class 2
Risk

K833819 is an FDA 510(k) clearance for the M305. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Burkick Corp. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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 Burkick Corp. devices

FDA 510(k) Submission Details - K833819

510(k) Number K833819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1983
Decision Date May 09, 1984
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXJ Device Classification - Class 2, Special Controls

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 68
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K833819.
SIRECUST 420 PATIENT DIALOG MONITOR
K851400 · Siemens Medical Solutions USA, Inc. · Jun 1985
DISPLAY MONITOR (VD-711RA-VD-712RA)
K850343 · Nihon Kohden America, Inc. · Apr 1985
SERVOMED MEDIVISION SCOPE SMV-235
K840209 · Litton Medical Electronics · Sep 1984
SERVOMED BASIC BEDSIDE UNIT SMVIII W
K831781 · Litton Medical Electronics · Nov 1983
SERVOMED BASIC BEDSIDE UNIT SMV 107
K831782 · Litton Medical Electronics · Nov 1983
SERVOMED BASIC BEDSIDE UNIT SMV 104
K831783 · Litton Medical Electronics · Nov 1983