510(k) · Cleared
ClearedDatex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin, E-Restin, E=Pretin, E-PP and E-PT/E-P)
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 Feb 3, 2006 as substantially equivalent to K041772 (Datex-Ohmeda, 2004) after a 267-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Feb 3, 2006
- Review
- 267 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041772 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK041772 Datex-Ohmeda Prestn.01 Module (Model Family M-Prestn.01) and…Datex-Ohmeda · 2004
- This deviceK051217 Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including…GE Healthcare · 2006
- Descendant · cites it directly · 0 of its ownK062324 Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options…GE Healthcare · 2006
Most influential descendants
Showing 1 of 1 · See all- K062324Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG…GE Healthcare · 2006 · cites it directly0descendants
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) | K051217 | Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin… | GE Healthcare | 2006 | — |
| +1 | K062324 | Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv… | GE Healthcare | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (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…S/5TM E-PRESTN Module family is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-PRESTN..01 Module (K041772).). DEVICE DESCRIPTION as required by 807.92(a)(4) The Datex-Ohmeda E-PRESTN module family and accessories is a hemodyn… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062324 | Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG… | 2006 | 0 |
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?
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 E-PRESTN module family (including E-PRESTN, E-RESTN, E-PRETN, E-PP, E-PT, and E-P modules) and accessories is 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 as stated in the FDA summary.
https://510kreport.com/device/K051217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051217: Datex-Ohmeda Prestin Module (Model Family E-Prestin, Including E-Prestin, E-Restin, E=Pretin, E-PP and E-PT/E-P).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051217
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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