510(k) · Cleared
ClearedDatex-Ohmeda Prestn Module, (Model Family M-Prestn) 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 Jun 25, 2003 as substantially equivalent to K993608 (Datex-Ohmeda, Inc., 2000) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jun 25, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010463 (2001). 3 ancestors in all, the oldest K993608 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK010463 Datex-Ohmeda Oxygen Saturation Module, M-Osat and AccessoiresDatex-Ohmeda, Inc. · 2001 · Recalled
- 1 generation backK011670 Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with…Datex-Ohmeda · 2001 · Recalled
- This deviceK031781 Datex-Ohmeda Prestn Module, (Model Family M-Prestn) and AccessoriesDatex-Ohmeda · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010463 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires | Datex-Ohmeda, Inc. | 2001 | 1 |
| −1 | K011670 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with… | Datex-Ohmeda | 2001 | 1 |
| 0 (this device) | K031781 | Datex-Ohmeda Prestn Module, (Model Family M-Prestn) and Accessories | Datex-Ohmeda | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K993608 | Datex-Ohmeda NE12STPR Module (Model Family M-NE12STPR)Summary page 2…The Datex-Ohmeda M-PRESTN Module is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-NE12STPR Module (K993608). DEVICE DESCRIPTION as required by 807.92(a)(4) The Datex-Ohmeda PRESTN module (model family M-PRESTN) and accessories… | 2000 |
| * | K011670 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with Trutrak+Motion… | 2001 |
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 2 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
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 PRESTN module (model family M-PRESTN) 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, Sp02 (including monitoring during conditions of clinical patient motion), and invasive blood pressure.
Impedance Respiration measurement is indicated for patients aged 3 and up.
The NIBP measurement is indicated for patients who weigh 5kg (11lb.) and up.
The device is indicated for use by quahfied medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031781: Datex-Ohmeda Prestn Module, (Model Family M-Prestn) 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/K031781
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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