510(k) · Cleared
ClearedUnity Network IS Patient Viewer
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 Aug 5, 2003 as substantially equivalent to K020661 (General Electric Medical Systems Information Techn, 2002) after a 6-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Aug 5, 2003
- Review
- 6 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K833395 (1984). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 4 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 3 generations backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- 2 generations backK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- 1 generation backK020661 Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn · 2002
- This deviceK032346 Unity Network IS Patient ViewerGe Medical Systems Information Technologies · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −4 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −3 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| −2 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| −1 | K020661 | Unity IS Patient Viewer | General Electric Medical Systems Information Techn | 2002 | — |
| 0 (this device) | K032346 | Unity Network IS Patient Viewer | Ge Medical Systems Information Technologies | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 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 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 |
|---|---|---|---|
| * | K020661 | Unity IS Patient Viewer | 2002 |
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
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@ IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network@IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity Network@IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the…
Read the full statement (107 words)
The Unity Network@ IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network@IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity Network@IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor.
The Unity Network@IS Patient Viewer is intended to provide near-real-time physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032346 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032346: Unity Network IS Patient Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032346
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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