510(k) · Cleared
ClearedDatex-Ohmeda S/5 PSM Module, (Consisting of E-PSM and E-PSMP Modules) and Accessories
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 Feb 18, 2005 as substantially equivalent to K041772 (Datex-Ohmeda, 2004) after a 57-day review. Its family tree reaches back 1 generation to 2004. 2 of the 17 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.
- Decided
- Feb 18, 2005
- Review
- 57 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041772 (2004). 15 later devices descend from it, 1 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK041772 Datex-Ohmeda Prestn.01 Module (Model Family M-Prestn.01) and…Datex-Ohmeda · 2004
- This deviceK043551 Datex-Ohmeda S/5 PSM Module, (Consisting of E-PSM and E-PSMP…Datex-Ohmeda · 2005
- Descendant · cites it directly · 14 of its ownK062576 Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and…GE Healthcare · 2006
- 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 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K062576Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm Modules) and…GE Healthcare · 2006 · cites it directly14descendants
- 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 | K041772 | Datex-Ohmeda Prestn.01 Module (Model Family M-Prestn.01) and Accessories | Datex-Ohmeda | 2004 | — |
| 0 (this device) | K043551 | Datex-Ohmeda S/5 PSM Module, (Consisting of E-PSM and E-PSMP Modules) and… | Datex-Ohmeda | 2005 | — |
| +1 | K062576 | Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm… | GE Healthcare | 2006 | — |
| +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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 1 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 1 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
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 |
|---|---|---|---|
| * | K041772 | Datex-Ohmeda Prestn.01 Module (Model Family M-Prestn.01) and AccessoriesSummary page 2…2 Respiration. The intended use for the modified device is the same as the predicate, Datex-Ohmeda M-PRESTN..0I module and accessories (K041772). The indications for use are also the same. There has been no change to the basic technology fiom the predicate. The Date… | 2004 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062576 | Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm Modules) and… | 2006 | 14 |
Has anything in its family been recalled? (2 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.
- K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- 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?
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 Datex-Ohmeda S/5 PSM module (consisting of E-PSM and E-PSMP modules) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO₂ (including monitoring during conditions of clinical patient motion), and invasive blood pressure.
Impedance Respiration measurement is indicated for patients ages 3 and up.
The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up.
The device 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/K043551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043551: Datex-Ohmeda S/5 PSM Module, (Consisting of E-PSM and E-PSMP Modules) and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043551
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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