Cleared Traditional

K833756 - SYSTEM 5000 (FDA 510(k) Clearance)

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

K833756 · Medical Graphics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
181d
Days
Class 2
Risk

K833756 is an FDA 510(k) clearance for the SYSTEM 5000. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Medical Graphics Corp. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1984 after a review of 181 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Medical Graphics Corp. devices

Submission Details

510(k) Number K833756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date April 24, 1984
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 176
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K833756.
Argos Infinity (Rev. 1.0)
K253092 · Retia Medical Systems, Inc. · Feb 2026
VitalStream ART Connect
K251275 · Caretaker Medical · Sep 2025
Cogent™ Hemodynamic Monitoring System
K232048 · Icu Medical · Dec 2023
Hypotension Decision Assist Model HDA-OR2
K212529 · Directed Systems, Ltd. · Nov 2021