510(k) · Cleared
Recalled · Class II · 2015MDP2000 Medical Data Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidco, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Oct 22, 1997 as substantially equivalent to K926162 (Vidco, Inc., 1993) and 4 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1993. It has been recalled once.
- Decided
- Oct 22, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 1 generation to K926162 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK926162 580CD Display DriverVidco, Inc. · 1993
- This deviceK972880 MDP2000 Medical Data ProcessorVidco, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926162 | 580CD Display Driver | Vidco, Inc. | 1993 | — |
| 0 (this device) | K972880 | MDP2000 Medical Data Processor | Vidco, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K926162 | 580CD Display DriverSummary page 1…8 Media for storage B Other devices to share information The MDP2000 is substantially equivalent to current and previously marketed VIDCO products: VIDCO model 580CD (K926162) VIDCO model 620CSR (K932894) VIDCO model 580CDR (K934093) VIDCO model 516YT (K926219) VIDCO model 520 (K926298) The MDP2000 has… | 1993 |
| * | K932894 | 620CSR Display DriverSummary page 1…devices to share information The MDP2000 is substantially equivalent to current and previously marketed VIDCO products: VIDCO model 580CD (K926162) VIDCO model 620CSR (K932894) VIDCO model 580CDR (K934093) VIDCO model 516YT (K926219) VIDCO model 520 (K926298) The MDP2000 has no new questions of safety o… | 1994 |
| * | K934093 | 580CDR Display DriverSummary page 1…The MDP2000 is substantially equivalent to current and previously marketed VIDCO products: VIDCO model 580CD (K926162) VIDCO model 620CSR (K932894) VIDCO model 580CDR (K934093) VIDCO model 516YT (K926219) VIDCO model 520 (K926298) The MDP2000 has no new questions of safety or effectiveness as it is perf… | 1994 |
| * | K926219 | 516YT Display DriverSummary page 1…y equivalent to current and previously marketed VIDCO products: VIDCO model 580CD (K926162) VIDCO model 620CSR (K932894) VIDCO model 580CDR (K934093) VIDCO model 516YT (K926219) VIDCO model 520 (K926298) The MDP2000 has no new questions of safety or effectiveness as it is performing essentially the same… | 1993 |
| * | K926298 | 520 Display Driver- Status ISummary page 1…d previously marketed VIDCO products: VIDCO model 580CD (K926162) VIDCO model 620CSR (K932894) VIDCO model 580CDR (K934093) VIDCO model 516YT (K926219) VIDCO model 520 (K926298) The MDP2000 has no new questions of safety or effectiveness as it is performing essentially the same functions as the predicate… | 1994 |
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 |
|---|---|---|---|---|
| Nov 8, 2015 | Class II | Z-0582-2016 | Device Design | Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condition, not allowing system to reset and reboot. Two customers recently complained of the system freezing and it could only be… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected. It accepts analog and/or digital physiological information from patient monitoring equipment and processes these signals to provide outputs to: Color monitors for local and remote display of information Chart recorders or printers for hardcopy records Media for storage Other devices to share information Examples of areas where the…
Read the full statement (114 words)
The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected. It accepts analog and/or digital physiological information from patient monitoring equipment and processes these signals to provide outputs to:
Color monitors for local and remote display of information
Chart recorders or printers for hardcopy records
Media for storage
Other devices to share information
Examples of areas where the MDP2000 is used include ICU, CCU, PACU, Emergency, Telemetry, Step-down and other areas where patient’s physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values such as heart rate and systolic, mean, and diastolic pressure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972880 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972880: MDP2000 Medical Data Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972880
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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