510(k) · Cleared
ClearedDatex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 Software
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 Jan 20, 2006 as substantially equivalent to K033078 (Datex-Ohmeda, 2003) after an 88-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Jan 20, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000647 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000647 Datex-Ohmeda Network and CentralDatex-Ohmeda, Inc. · 2000
- 3 generations backK013387 Datex-Ohmeda S/5 Web ViewerDatex-Ohmeda · 2002
- 2 generations backK023497 Datex-Ohmeda S/5 Web Viewer with L-6WV02 SoftwareDatex-Ohmeda · 2002
- 1 generation backK033078 Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03…Datex-Ohmeda · 2003
- This deviceK052975 Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and…GE Healthcare · 2006
- Descendant · cites it directly · 0 of its ownK070204 Link to Acuity Clinician NotifierWelch Allyn Protocol, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070204Link to Acuity Clinician NotifierWelch Allyn Protocol, Inc. · 2007 · cites it directly0descendants
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 | K013387 | Datex-Ohmeda S/5 Web Viewer | Datex-Ohmeda | 2002 | — |
| −2 | K023497 | Datex-Ohmeda S/5 Web Viewer with L-6WV02 Software | Datex-Ohmeda | 2002 | — |
| −1 | K033078 | Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software | Datex-Ohmeda | 2003 | — |
| 0 (this device) | K052975 | Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda… | GE Healthcare | 2006 | — |
| +1 | K070204 | Link to Acuity Clinician Notifier | Welch Allyn Protocol, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K033078 | Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 SoftwareSummary page 2…ntially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Web Viewer and Datex-Ohmeda S/5 Pocket Viewer versions (K033078) currently in distribution. DEVICE DESCRIPTION as required by 807.92(a)(4) The Datex-Ohmeda S/5 Web Viewer is a supplem… | 2003 |
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 |
|---|---|---|---|
| K070204 | Link to Acuity Clinician Notifier | 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 6 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070204 (Welch Allyn Protocol, Inc., 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?
Indication for use for S/5 Web Viewer: The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Web Viewer clients The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network.…
Read the full statement (425 words)
Indication for use for S/5 Web Viewer: The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Web Viewer clients The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.
Indication for use for S/5 Pocket Viewer: The Datex-Ohmeda S/5 Pocket Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Pocket Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Pocket Viewer clients. The S/5 Pocket Viewer client runs on a generic handheld computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.
Indication for use for S/5 Cellular Viewer: The Datex-Ohmeda S/5 Cellular Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Cellular Viewer client runs on a generic cellular phone that is connected to the hospital local area network. The Datex-Ohmeda S/5 Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Cellular Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Cellular Viewer is not a primary alarm source. The device is for use by qualified personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052975: Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052975
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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