# K050951: Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360; Medstar 370, Model 533-370

- Pathway: 510(k) (Traditional)
- Applicant: Cibernet Systems Corp.
- Decided: Jul 19, 2005 after 95 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K864318 (1987). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020534: Medstar System, Models 533-300, Cybernet Medical (2003) Summary page 1.
- K040651: Hommed Sentry Iiib-F Patient Monitor System, Hommed, LLC (2004) Summary page 1.
- K030419: Viterion 100 Telehealth Monitor, Viterion Telehealthcare, LLC (2003) Summary page 1.

## Recalls of this device
- Jan 23, 2008 · Not classified · Z-0854-2010: A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
- Jan 23, 2008 · Not classified · Z-0855-2010: A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
- Jan 23, 2008 · Not classified · Z-0852-2010: A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
- Jan 23, 2008 · Not classified · Z-0853-2010: A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.

## Indications for use
The MedStar System is indicated for Out-of-Hospital Use with any patient requiring Out-of-Hospital monitoring. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital -Type facility, Medical Clinic or Physician's Office.

Source page: https://510kreport.com/device/K050951
Methodology: https://510kreport.com/methodology