Cleared Traditional

MEDSTAR 220, MODEL 533-220 (K050951) - FDA 510(k) Clearance

Also marketed or referenced as:
MEDSTAR 230, MODEL 533-230 MEDSTAR 360, MODEL 533-360 MEDSTAR 370, MODEL 533-370

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

K050951 · Cibernet Systems Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
95d
Days
Class 2
Risk

K050951 is an FDA 510(k) clearance for the MEDSTAR 220, MODEL 533-220. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Cibernet Systems Corp. (Ann Arbor, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Cibernet Systems Corp. devices

Submission Details

510(k) Number K050951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2005
Decision Date July 19, 2005
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 53
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K050951.
FibriCheck
K173872 · Qompium NV · Sep 2018
CARDIOSKIN
K173248 · Bioserenity Sas · Aug 2018
QT ECG
K180157 · QT Medical, Inc. · May 2018
MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR
K915769 · Medtronic Vascular · Jan 1992
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)
K913533 · Hewlett-Packard Co. · Nov 1991
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084 · Medtronic Vascular · Jul 1991