510(k) · Cleared
ClearedDatex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · DSI Detector And Alarm, Arrhythmia
Cleared on Jul 24, 2002 as substantially equivalent to K000168 (Datex-Ohmeda, 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jul 24, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000168 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000168 CS/3 Critical Care Monitor with S-ICU99(a)Datex-Ohmeda · 2000
- This deviceK021376 Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A…Datex-Ohmeda · 2002
- Descendant · cites it directly · 0 of its ownK071889 Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A…GE Healthcare · 2008
Most influential descendants
Showing 1 of 1 · See all- K071889Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A SoftwareGE Healthcare · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000168 | CS/3 Critical Care Monitor with S-ICU99(a) | Datex-Ohmeda | 2000 | — |
| 0 (this device) | K021376 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software | Datex-Ohmeda | 2002 | — |
| +1 | K071889 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software | GE Healthcare | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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 |
|---|---|---|---|
| * | K000168 | CS/3 Critical Care Monitor with S-ICU99(a)Summary page 4…L-ICUOZ and L-ICU02A software is substantially equivalent to the predicate Datex-Ohmeda CS/3TMCritical Care Monitor with S-ICUS)s)(A)sofhvare (K000168). The S/5m Critical Care Monitor with L-ICUOZ and L-ICUOZA software is indicated for monitoring of hem… | 2000 |
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 |
|---|---|---|---|
| K071889 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K071889 (GE Healthcare, 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients.
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents.
The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software is 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/K021376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021376: Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021376
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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