510(k) · Cleared
Recalled · 2008Medstar System, Models 533-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybernet Medical · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Feb 11, 2003 as substantially equivalent to K010029 (Avid Care Corp., 2001) and 2 other predicates after a 357-day review. Its family tree reaches back 1 generation to 1992. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 11, 2003
- Review
- 357 days
- Class
- Class II
- Product code
- DXH
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K915632 (1992). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK915632 Paceart CPTS-86/12Paceart, Inc. · 1992
- This deviceK020534 Medstar System, Models 533-300Cybernet Medical · 2003
- Descendant · cites it directly · 8 of its ownK041854 MPM SystemAerotel Medical Systems, Ltd. · 2004
- Descendant · cites it directly · 7 of its ownK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- Descendant · 2 generations on · 4 of its ownK063008 Health Check KioskXperex Corporation · 2007
- Descendant · 2 generations on · 1 of its ownK151839 AMC Health VitalCaregiving SystemAmc Health · 2016
- Descendant · 3 generations on · 1 of its ownK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K041854MPM SystemAerotel Medical Systems, Ltd. · 2004 · cites it directly8descendants
- K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005 · cites it directly7descendants
- K063008Health Check KioskXperex Corporation · 2007 · 2 generations on4descendants
- K151839AMC Health VitalCaregiving SystemAmc Health · 2016 · 2 generations on1descendant
- K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915632 | Paceart CPTS-86/12 | Paceart, Inc. | 1992 | — |
| 0 (this device) | K020534 | Medstar System, Models 533-300 | Cybernet Medical | 2003 | — |
| +1 | K041854 | MPM System | Aerotel Medical Systems, Ltd. | 2004 | — |
| +1 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| +2 | K063008 | Health Check Kiosk | Xperex Corporation | 2007 | — |
| +2 | K151839 | AMC Health VitalCaregiving System | Amc Health | 2016 | — |
| +3 | K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K010029 | Home Health Monitoring System | 2001 |
| * | K003257 | EHC400 Desktop Patient Station; ECH600 Care Provider Station | 2000 |
| * | K915632 | Paceart CPTS-86/12Summary page 1…AvidCare Corp., KO10029 Model EHC 400 Desktop Patient Station, Cybercare Technologies Inc., KO03257 PaceArt Central Station CPTS 86-12, PaceArt Inc., K915632 Section 16.e Device Description & Technological Characteristics The MedStar Monitoring System comprises the MedStar… | 1992 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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/K020534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020534: Medstar System, Models 533-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020534
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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