510(k) · Cleared
ClearedDatex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · DSI Detector And Alarm, Arrhythmia
Cleared on May 19, 2008 as substantially equivalent to K021376 (Datex-Ohmeda, 2002) after a 315-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- May 19, 2008
- Review
- 315 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000168 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK000168 CS/3 Critical Care Monitor with S-ICU99(a)Datex-Ohmeda · 2000
- 1 generation backK021376 Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A…Datex-Ohmeda · 2002
- This deviceK071889 Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A…GE Healthcare · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000168 | CS/3 Critical Care Monitor with S-ICU99(a) | Datex-Ohmeda | 2000 | — |
| −1 | K021376 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A Software | Datex-Ohmeda | 2002 | — |
| 0 (this device) | K071889 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software | GE Healthcare | 2008 | — |
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 |
|---|---|---|---|
| * | K021376 | Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A SoftwareSummary page 2…with L-ICU05and L-ICU05A software is substantially equivalent to the predicate Datex-Ohmeda S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software (K021376). DEVICE DESCRIPTION as required by 807.92(a)(4) The two software options for the S/5 TM Critical Care Monitor are iden… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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-ICU05 and L-ICU05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, and neurophysiological status of all patients. When the BIS module is used with the S/5 Critical Care Monitor with L-ICU05 and L-ICU05A, it is intended for use by personnel trained in its proper use. It is intended for use on adult and…
Read the full statement (179 words)
The S/5 Critical Care Monitor with L-ICU05 and L-ICU05A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, and neurophysiological status of all patients.
When the BIS module is used with the S/5 Critical Care Monitor with L-ICU05 and L-ICU05A, it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS measurement, may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgement and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population.
The S/5 Critical Care Monitor with L-ICU05 and L-ICU05A software is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071889: Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071889
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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