510(k) · Cleared
Recalled · 2006Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · MLD Monitor, St Segment With Alarm
Cleared on Nov 14, 2002 as substantially equivalent to K002158 (Datex-Ohmeda, Inc., 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 2 of the 15 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 14, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- MLD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002158 (2000). 13 later devices descend from it, 2 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK002158 S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 SoftwareDatex-Ohmeda, Inc. · 2000
- This deviceK022740 Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 &…Datex-Ohmeda · 2002
- Descendant · cites it directly · 11 of its ownK043276 Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and…Datex-Ohmeda · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 7 of its ownK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
- Descendant · 5 generations on · 5 of its ownK151063 Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · cites it directly11descendants
- K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 2 generations on10descendants
- K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 3 generations on8descendants
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on7descendants
- K151063Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002158 | S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 Software | Datex-Ohmeda, Inc. | 2000 | — |
| 0 (this device) | K022740 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A… | Datex-Ohmeda | 2002 | — |
| +1 | K043276 | Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module | Datex-Ohmeda | 2004 | Class I |
| +2 | K120598 | Procare Monitor B40 | Ge Medical Systems China Co., Ltd. | 2012 | 2 |
| +3 | K130584 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2013 | 2 |
| +4 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | Class I |
| +5 | K151063 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 1 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K002158 | S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 SoftwareSummary page 4…S/STMCompact Critical Care Monitor with L-CICUO2, which is a new revision of the predicate devices, S/STMCompact Critical Care Monitor with S-OOCO3 software (K002158). The S/STMCompact Critical Care Monitor with L-CICUO2 may be equipped with extended bedside arrhythrma analysis capability… | 2000 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2006 | Not classified | Z-1995-2009 | Software design | GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was… |
| Feb 6, 2006 | Not classified | Z-1994-2009 | Software design | GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K043276 (Datex-Ohmeda, 2004) has gone furthest, with 11 descendants of its own.
How does its category compare?
All MLD devicesMLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLD
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MLD
Too few MLD 510(k)s in any year since 2007 to give a median.
Recalls per year · MLD
No recall names MLD since 2007.
Adverse event reports per year · MLD
1in 2019
MAUDE reports naming product code MLD, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The S / 5 T M Compact Critical Care Monitor with L-CICUO2 and L-CICU02A 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 T M Compact Critical Care Monitor with L-CICUO2 and L-CICU02A software when using BIS is for monitoring the state of the brain by…
Read the full statement (113 words)
The S / 5 T M Compact Critical Care Monitor with L-CICUO2 and L-CICU02A 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 T M Compact Critical Care Monitor with L-CICUO2 and L-CICU02A 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 T M Compact Critical Care Monitor with L-CICUO2 and L-CICU02A software is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022740 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022740: Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022740
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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