# K020534: Medstar System, Models 533-300

- Pathway: 510(k) (Traditional)
- Applicant: Cybernet Medical
- Decided: Feb 11, 2003 after 357 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: 1 generation back to K915632 (1992). 3 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010029: Home Health Monitoring System, Avid Care Corp. (2001)
- K003257: EHC400 Desktop Patient Station; ECH600 Care Provider Station, Cybercare Technologies, Inc. (2000)
- K915632: Paceart CPTS-86/12, Paceart, Inc. (1992) Summary page 1.

## Most influential descendants
- K041854: MPM System (2004), 8 descendants of its own
- K051544: Vitalcaregiving System (2005), 7 descendants of its own
- K063008: Health Check Kiosk (2007), 4 descendants of its own
- K151839: AMC Health VitalCaregiving System (2016), 1 descendant of its own
- K101198: Csi Managed Health System Model: Csi Model 9K (2010), 1 descendant of its own

## 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/K020534
Methodology: https://510kreport.com/methodology