510(k) · Cleared
ClearedUnity Network Patient Data Server
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MSX System, Network And Communication, Physiological Monitors
Cleared on Sep 17, 2003 as substantially equivalent to K001268 (General Electric Medical Systems Information Techn, 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Sep 17, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001268 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001268 GE Marquette Prism Information Server ApplicationsGeneral Electric Medical Systems Information Techn · 2000
- This deviceK032582 Unity Network Patient Data ServerGe Medical Systems Information Technologies · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001268 | GE Marquette Prism Information Server Applications | General Electric Medical Systems Information Techn | 2000 | — |
| 0 (this device) | K032582 | Unity Network Patient Data Server | Ge Medical Systems Information Technologies | 2003 | — |
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? (1)
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 |
|---|---|---|---|
| * | K001268 | GE Marquette Prism Information Server Applications | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K001268.
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 Unity Network@Patient Data Server (PDS) is intended for use under the direct supervision of a licensed healthcare practitioner. The Unity Network@ Patient Data Server is intended to provide centralized intermediate term storage of patient centric events and physiological data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Patient events and physiological data stored at the Unity Network@ Patient Data…
Read the full statement (116 words)
The Unity Network@Patient Data Server (PDS) is intended for use under the direct supervision of a licensed healthcare practitioner. The Unity Network@ Patient Data Server is intended to provide centralized intermediate term storage of patient centric events and physiological data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Patient events and physiological data stored at the Unity Network@ Patient Data Server can be accessed via any (authorized) device that implements the PDS data exchange protocol. The Unity Network Patient Data Server is NOT intended to be the sole source for patient data and is to be used in conjunction with the data at the bedside monitor and central monitoring station.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032582: Unity Network Patient Data Server.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032582
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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