510(k) · Cleared
ClearedDatex-Ohmeda Network and Central
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Jul 13, 2000 after a 136-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jul 13, 2000
- Review
- 136 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
- Descendant · cites it directly · 10 of its ownK013246 Datex-Ohmeda S/5 Network and Central '01Datex-Ohmeda · 2001
- Descendant · 2 generations on · 9 of its ownK022507 Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda · 2002
- Descendant · 3 generations on · 7 of its ownK033281 Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03…Datex-Ohmeda · 2003
- Descendant · 4 generations on · 6 of its ownK042771 GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3Datex-Ohmeda · 2004
- Descendant · 5 generations on · 5 of its ownK052972 Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare · 2005 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K013246Datex-Ohmeda S/5 Network and Central '01Datex-Ohmeda · 2001 · cites it directly10descendants
- K022507Datex-Ohmeda S/5 Network and Central '02Datex-Ohmeda · 2002 · 2 generations on9descendants
- K033281Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 SoftwareDatex-Ohmeda · 2003 · 3 generations on7descendants
- K042771GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3Datex-Ohmeda · 2004 · 4 generations on6descendants
- K052972Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3GE Healthcare · 2005 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000647 | Datex-Ohmeda Network and Central | Datex-Ohmeda, Inc. | 2000 | — |
| +1 | 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 | — |
| +3 | K033281 | Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 Software | Datex-Ohmeda | 2003 | — |
| +4 | K042771 | GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3 | Datex-Ohmeda | 2004 | — |
| +5 | K052972 | Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3 | GE Healthcare | 2005 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K013246 (Datex-Ohmeda, 2001) has gone furthest, with 10 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 | — |
https://510kreport.com/device/K000647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000647: Datex-Ohmeda Network and Central.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000647
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026