510(k) · Cleared
ClearedDatex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx
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 Nov 2, 2001 as substantially equivalent to K935477 (Datex Division Instrumentarium Corp., 1994) after an 88-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Nov 2, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935477 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK935477 AS/3(TM) Anesthesia Monitor Syst Interface BoardDatex Division Instrumentarium Corp. · 1994
- This deviceK012531 Datex-Ohmeda S/5 Device Interfacing Solution, N-DisxxxxDatex-Ohmeda · 2001
- Descendant · cites it directly · 1 of its ownK051634 Datex-Ohmeda S/5 Device Interfacing SolutionGE Healthcare · 2005
- Descendant · 2 generations on · 0 of its ownK070421 Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with…GE Healthcare · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935477 | AS/3(TM) Anesthesia Monitor Syst Interface Board | Datex Division Instrumentarium Corp. | 1994 | — |
| 0 (this device) | K012531 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx | Datex-Ohmeda | 2001 | — |
| +1 | K051634 | Datex-Ohmeda S/5 Device Interfacing Solution | GE Healthcare | 2005 | — |
| +2 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K935477 | AS/3(TM) Anesthesia Monitor Syst Interface BoardSummary page 2…7.92(a)(3) The S/5™ Device Interfacing Solution is substantially equivalent in safety and effectiveness to the legally marketed (predicate) AS/3 Interface Board, B-INT (K935477). DEVICE DESCRIPTION as required by 807.92(a)(4) The Device Interfacing Solution (DIS) has the following key components: Device… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051634 | Datex-Ohmeda S/5 Device Interfacing Solution | 2005 | 1 |
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?
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 is indicated for data transfer from ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heartlung machines to Datex-Ohmeda bedside monitors for displaying and patient care information purposes.
The devices are indicated for use by qualified medical personnel only.
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/K012531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012531: Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012531
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026