510(k) · Cleared
ClearedDatex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 18, 2007 as substantially equivalent to K022740 (Datex-Ohmeda, 2002) after a 69-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jun 18, 2007
- Review
- 69 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002158 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK002158 S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 SoftwareDatex-Ohmeda, Inc. · 2000
- 1 generation backK022740 Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 &…Datex-Ohmeda · 2002 · Recalled
- This deviceK071020 Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU05 and…GE Healthcare · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002158 | S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 Software | Datex-Ohmeda, Inc. | 2000 | — |
| −1 | K022740 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A… | Datex-Ohmeda | 2002 | 2 |
| 0 (this device) | K071020 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A… | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K022740 | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A SoftwareSummary page 2…and L-CICU05A software is substantially equivalent to the predicate Datex-Ohmeda S/5TM Compact Critical Care Monitor with L-CICU02 and L-CICU02A software (K022740). DEVICE DESCRIPTION as required by 807.92(a)(4) The two software options for the S/5 TM Compact Critical Care Monitor… | 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 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K022740.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The S/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A 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/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A software when using BIS is for monitoring the state of the brain by data…
Read the full statement (101 words)
The S/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A 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/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A 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/5TM Compact Critical Care Monitor with L-CICU05 and L-CICU05A software is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071020 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071020: Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071020
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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