510(k) · Cleared
ClearedUnity IS Patient Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · MSX System, Network And Communication, Physiological Monitors
Cleared on May 24, 2002 as substantially equivalent to K001268 (General Electric Medical Systems Information Techn, 2000) and 1 other predicate after an 84-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it.
- Decided
- May 24, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K833395 (1984). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 3 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 2 generations backK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- 1 generation backK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- This deviceK020661 Unity IS Patient ViewerGeneral Electric Medical Systems Information Techn · 2002
- Descendant · cites it directly · 0 of its ownK032346 Unity Network IS Patient ViewerGe Medical Systems Information Technologies · 2003
Most influential descendants
Showing 1 of 1 · See all- K032346Unity Network IS Patient ViewerGe Medical Systems Information Technologies · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −3 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −2 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| −1 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| 0 (this device) | K020661 | Unity IS Patient Viewer | General Electric Medical Systems Information Techn | 2002 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 ApplicationsSummary page 1…ewer Common/Usual Name: Computer, Information Network Server Classification Names: 21 CFR 870.2300 System, Network and Communication, Physiological Predicate Devices: K001268 GE Marquette Prism Information Server Applications (MPIS) K993008 Quantitative Sentinel System (Specific features) The Unity® IS… | 2000 |
| * | K993008 | Quantitative Sentinel SystemSummary page 1…sification Names: 21 CFR 870.2300 System, Network and Communication, Physiological Predicate Devices: K001268 GE Marquette Prism Information Server Applications (MPIS) K993008 Quantitative Sentinel System (Specific features) The Unity® IS Patient Viewer provides remote access to waveform, parameter data… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032346 | Unity Network IS Patient Viewer | 2003 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K032346 (Ge Medical Systems Information Technologies, 2003) has gone furthest, with 0 descendants of its own.
- 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® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity® 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® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor.
The Unity® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020661: Unity IS Patient Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020661
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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