510(k) · Cleared
ClearedGE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · MSX System, Network And Communication, Physiological Monitors
Cleared on Oct 15, 2004 as substantially equivalent to K033281 (Datex-Ohmeda, 2003) after a 10-day review. Its family tree reaches back 4 generations to 2000. 6 later devices descend from it.
- Decided
- Oct 15, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000647 (2000). 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
- 3 generations backK013246 Datex-Ohmeda S/5 Network and Central '01Datex-Ohmeda · 2001
- 2 generations backK022507 Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda · 2002
- 1 generation backK033281 Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03…Datex-Ohmeda · 2003
- This deviceK042771 GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3Datex-Ohmeda · 2004
- Descendant · cites it directly · 5 of its ownK052972 Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare · 2005 · Recalled
- Descendant · 2 generations on · 4 of its ownK071097 Navigator Applications SuiteGE Healthcare Finland Oy · 2007
- Descendant · 3 generations on · 3 of its ownK081941 Navigator Applications SuiteGE Healthcare Finland Oy · 2008
- Descendant · 3 generations on · 2 of its ownK083098 Navigator Applications SuiteGE Healthcare Finland Oy · 2009
- Descendant · 3 generations on · 1 of its ownK102389 Navigator Applications SuiteGE Healthcare Finland Oy · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K052972Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare · 2005 · cites it directly5descendants
- K071097Navigator Applications SuiteGE Healthcare Finland Oy · 2007 · 2 generations on4descendants
- K081941Navigator Applications SuiteGE Healthcare Finland Oy · 2008 · 3 generations on3descendants
- K083098Navigator Applications SuiteGE Healthcare Finland Oy · 2009 · 3 generations on2descendants
- K102389Navigator Applications SuiteGE Healthcare Finland Oy · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000647 | Datex-Ohmeda Network and Central | Datex-Ohmeda, Inc. | 2000 | — |
| −3 | K013246 | Datex-Ohmeda S/5 Network and Central '01 | Datex-Ohmeda | 2001 | — |
| −2 | K022507 | Datex-Ohmeda S/5 Network and Central '02 | Datex-Ohmeda | 2002 | — |
| −1 | K033281 | Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 Software | Datex-Ohmeda | 2003 | — |
| 0 (this device) | K042771 | GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3 | Datex-Ohmeda | 2004 | — |
| +1 | K052972 | Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3 | GE Healthcare | 2005 | 3 |
| +2 | K071097 | Navigator Applications Suite | GE Healthcare Finland Oy | 2007 | — |
| +3 | K081941 | Navigator Applications Suite | GE Healthcare Finland Oy | 2008 | — |
| +3 | K083098 | Navigator Applications Suite | GE Healthcare Finland Oy | 2009 | — |
| +3 | K102389 | Navigator Applications Suite | GE Healthcare Finland Oy | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K033281 | Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 SoftwareSummary page 2…twork corresponds to the structure and functionality of the substantially equivalent predicate device Datex-Ohmneda Network and Central '03 (510(k) number: K033281). The (.E Datex-Ohmeda Network will be used for real-time communication between devices, for record keeping and for… | 2003 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052972 | Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3 | 2005 | 5 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052972 (GE Healthcare, 2005) has gone furthest, with 5 descendants of its own.
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 GE Datex-Ohmeda S/5 TM Network and Central transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several iCentrals. Within one Datex-Ohmeda monitor network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The GE Datex-Ohmeda S/5TM iCentral maintains the network connections between the…
Read the full statement (173 words)
The GE Datex-Ohmeda S/5 TM Network and Central transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several iCentrals. Within one Datex-Ohmeda monitor network it allows a networked device to display, store, print and otherwise process information received from other networked devices.
The GE Datex-Ohmeda S/5TM iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in GE Datex-Ohmeda monitor network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the GE Datex-Ohmeda S/5 TM Network as well as between the GE Datex-Ohmeda Network and Hospital Information Systems (HIS).
The GE Datex-Ohmeda S/5TM iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices.
The GE Datex-Ohmeda S/5 TM Network will be used for patients in the hospital and it is meant for continuous use.
The device is for use by qualified personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042771 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042771: GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042771
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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