510(k) · Cleared
Recalled · 2009Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02
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 Mar 13, 2007 as substantially equivalent to K051634 (GE Healthcare, 2005) after a 28-day review. Its family tree reaches back 3 generations to 1994. It has been recalled once.
- Decided
- Mar 13, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935477 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK935477 AS/3(TM) Anesthesia Monitor Syst Interface BoardDatex Division Instrumentarium Corp. · 1994
- 2 generations backK012531 Datex-Ohmeda S/5 Device Interfacing Solution, N-DisxxxxDatex-Ohmeda · 2001
- 1 generation backK051634 Datex-Ohmeda S/5 Device Interfacing SolutionGE Healthcare · 2005
- This deviceK070421 Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with…GE Healthcare · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935477 | AS/3(TM) Anesthesia Monitor Syst Interface Board | Datex Division Instrumentarium Corp. | 1994 | — |
| −2 | 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 | — |
| 0 (this device) | K070421 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02 | GE Healthcare | 2007 | — |
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 |
|---|---|---|---|
| * | K051634 | Datex-Ohmeda S/5 Device Interfacing SolutionSummary page 1…S VENT. .02 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) S/5TM Device Interfacing Solution, N-DlSxxxx..0l (K05 1634). Page 2 of 4… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2009 | Not classified | Z-1558-2009 | Software design | GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
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. 2007, this device’s year, is highlighted.
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 with N-DISVENT..02, 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/K070421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070421: Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070421
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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