510(k) · Cleared
ClearedDatex-Ohmeda S/5 Device Interfacing Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MSX System, Network And Communication, Physiological Monitors
Cleared on Jul 19, 2005 as substantially equivalent to K012531 (Datex-Ohmeda, 2001) after a 29-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jul 19, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935477 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK935477 AS/3(TM) Anesthesia Monitor Syst Interface BoardDatex Division Instrumentarium Corp. · 1994
- 1 generation backK012531 Datex-Ohmeda S/5 Device Interfacing Solution, N-DisxxxxDatex-Ohmeda · 2001
- This deviceK051634 Datex-Ohmeda S/5 Device Interfacing SolutionGE Healthcare · 2005
- Descendant · cites it directly · 0 of its ownK070421 Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with…GE Healthcare · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K070421Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02GE Healthcare · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935477 | AS/3(TM) Anesthesia Monitor Syst Interface Board | Datex Division Instrumentarium Corp. | 1994 | — |
| −1 | K012531 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx | Datex-Ohmeda | 2001 | — |
| 0 (this device) | K051634 | Datex-Ohmeda S/5 Device Interfacing Solution | GE Healthcare | 2005 | — |
| +1 | K070421 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02 | GE Healthcare | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K012531 | Datex-Ohmeda S/5 Device Interfacing Solution, N-DisxxxxSummary page 1…Sxxxx..0l is substantially equivalent in safety and effectiveness to the legally marketed (predicate) S/5 T MDevice Interfacing Solution, N- DISxxxx..00 (K01253 1). ko'i 6S4… | 2001 |
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 |
|---|---|---|---|
| K070421 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02 | 2007 | 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 11 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K070421 (GE Healthcare, 2007) has gone furthest, with 0 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 Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051634: Datex-Ohmeda S/5 Device Interfacing Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051634
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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