510(k) · Cleared
Recalled · 2008Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360; Medstar 370, Model 533-370
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cibernet Systems Corp. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jul 19, 2005 as substantially equivalent to K020534 (Cybernet Medical, 2003) and 2 other predicates after a 95-day review. Its family tree reaches back 3 generations to 1987. It has been recalled 4 times.
- Decided
- Jul 19, 2005
- Review
- 95 days
- Class
- Class II
- Product code
- DXH
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864318 (1987). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 2 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 1 generation backK030419 Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC · 2003 · Recalled
- This deviceK050951 Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360…Cibernet Systems Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −2 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −1 | K030419 | Viterion 100 Telehealth Monitor | Viterion Telehealthcare, LLC | 2003 | 2 |
| 0 (this device) | K050951 | Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model… | Cibernet Systems Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020534 | Medstar System, Models 533-300Summary page 1…0:k*bMaqefactue 51k MedStar System Cybernet Medical K020534 HomMed Sentry IIIB-F Patient HomMed LLC K040651 Monitor System Viterion 100 TeleH… | 2003 |
| * | K040651 | Hommed Sentry Iiib-F Patient Monitor SystemSummary page 1…51k MedStar System Cybernet Medical K020534 HomMed Sentry IIIB-F Patient HomMed LLC K040651 Monitor System Viterion 100 TeleHealth Monitor Viterion TeleHealthcare LLC K030419 The MedStar Syste… | 2004 |
| * | K030419 | Viterion 100 Telehealth MonitorSummary page 1…Med Sentry IIIB-F Patient HomMed LLC K040651 Monitor System Viterion 100 TeleHealth Monitor Viterion TeleHealthcare LLC K030419 The MedStar System II's Intended Use, Indications for Use, feature set and performance specifications are similar… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2008 | Not classified | Z-0854-2010 | Component design/selection | 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 | Component design/selection | 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 | Component design/selection | 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 | Component design/selection | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K020534.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050951 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050951: Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360; Medstar 370, Model 533-370.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050951
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026