510(k) · Cleared
ClearedDatex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jul 23, 2004 as substantially equivalent to K022485 (Datex-Ohmeda, 2002) after a 21-day review. Its family tree reaches back 2 generations to 2000. 1 of the 87 devices in its family, counting itself, has a Class I recall. 84 later devices descend from it.
- Decided
- Jul 23, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002478 (2000). 84 later devices descend from it, 3 citing it directly. 1 of the 87 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK002478 S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08Datex-Ohmeda, Inc. · 2000
- 1 generation backK022485 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and…Datex-Ohmeda · 2002
- This deviceK041790 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and…Datex-Ohmeda · 2004
- Descendant · cites it directly · 48 of its ownK053193 PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · 2 generations on · 47 of its ownK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · cites it directly · 34 of its ownK061185 Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and…GE Healthcare · 2006
- Descendant · 2 generations on · 32 of its ownK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- Descendant · 3 generations on · 19 of its ownK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B404 generations on · 2014
Most influential descendants
Showing 5 of 84 · See all- K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · cites it directly48descendants
- K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on47descendants
- K061185Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A SoftwareGE Healthcare · 2006 · cites it directly34descendants
- K102239Carescape Monitor B650GE Healthcare Finland Oy · 2010 · 2 generations on32descendants
- K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002478 | S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08 | Datex-Ohmeda, Inc. | 2000 | — |
| −1 | K022485 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A Software | Datex-Ohmeda | 2002 | — |
| 0 (this device) | K041790 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A Software | Datex-Ohmeda | 2004 | — |
| +1 | K053193 | PM-8000 Express Patient Monitor, Model PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +2 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +1 | K061185 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A… | GE Healthcare | 2006 | — |
| +2 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| +3 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 1 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K022485 | Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A SoftwareSummary page 1…ubstantially equivalent to the predicate Datex-Ohmeda TM S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (K022485). Ko LH75c… | 2002 |
| † | K023459 | Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories | 2003 |
What descends from it? (84)
See all 843 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K053193 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2006) has gone furthest, with 48 descendants of its own.
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.
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/5 T Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients. The S/5 TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software when using BIS is for…
Read the full statement (127 words)
The S/5 T Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients.
The S/5 TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A 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 TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is also indicated for documenting patient care related information.
The S/5 TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041790 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041790: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041790
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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