510(k) · Cleared
ClearedMenntor X7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Ltd. · DSI Detector And Alarm, Arrhythmia
Cleared on Jan 9, 2015 as substantially equivalent to K093766 (Mennen Medical, Ltd., 2010) and 1 other predicate after a 221-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jan 9, 2015
- Review
- 221 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001120 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK001120 Envoy Patient MonitorMennen Medical, Ltd. · 2001
- 2 generations backK011784 Modification to Envoy Patient MonitorMennen Medical, Ltd. · 2001
- 1 generation backK030722 Envoy Patient MonitorMennen Medical, Inc. · 2004
- This deviceK141441 Menntor X7Mennen Medical, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001120 | Envoy Patient Monitor | Mennen Medical, Ltd. | 2001 | — |
| −2 | K011784 | Modification to Envoy Patient Monitor | Mennen Medical, Ltd. | 2001 | — |
| −1 | K030722 | Envoy Patient Monitor | Mennen Medical, Inc. | 2004 | — |
| 0 (this device) | K141441 | Menntor X7 | Mennen Medical, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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 |
|---|---|---|---|
| * | K093766 | Vitalogik 6000/6500Summary page 4…ion Class 11 8. Product Code DSI 9. Reviewing Panel Cardiovascular 10. Performance Standards Please see page 15, 16 11. 510(k) Marketing clearance for VitaLogik 6000 K093766 — May 7, 2010 Page 1 of 16 K141441 Terminology Menntor X7 = subject of this Traditional 510(k). The Menntor X7… | 2010 |
| * | K030722 | Envoy Patient MonitorSummary page 5…d also with CerebraLogik in (K131789 dated 27.12.2013) Envoy monitor with Spirometry module = the predicated device The Envoy monitor was approved for marketing by FDA (K030722 dated 26.2.2004) Definition of Product Family: The Menntor X7 is a new member of the Envoy /VitaLogik family. It uses the same… | 2004 |
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 14 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Menntor X7 is intended for use as a multi-parameter physiological patient monitoring system. The Menntor X7, is a modular monitor with a Multi Parameter Module (MX57, MPM) that can monitor ECG/heart rate, invasive blood pressures , temperature, pulse oximetry, respiration, non-invasive blood pressure, and Cardiac Output The Menntor X7 can also monitor EtCO2, Spirometry and EEG, and display aEEG. The MPM (MX57) is equipped with a battery and can continue…
Read the full statement (186 words)
Menntor X7 is intended for use as a multi-parameter physiological patient monitoring system.
The Menntor X7, is a modular monitor with a Multi Parameter Module (MX57, MPM) that can monitor ECG/heart rate, invasive blood pressures , temperature, pulse oximetry, respiration, non-invasive blood pressure, and Cardiac Output
The Menntor X7 can also monitor EtCO2, Spirometry and EEG, and display aEEG.
The MPM (MX57) is equipped with a battery and can continue monitoring it's vital sign when out of the host Menntor X7
This effectively allows the Menntor X7 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
Functions include display of multi-parameter waveforms, vital signs, alarm & status messages.
The Mennen Medical Menntor X7 is intended for sale as a system for monitoring and recording patient information on any in-hospital application requiring patient monitoring.
The following are examples of intended clinical applications:
» Critical Care Patients
* Cardiac Step-down Units
* Emergency Departments
* Intra-operative (Anesthesia) Monitoring
* Post Anesthesia Care
*The Intended Use of the Menntor X7 as indicated above is same as the Indications For Use.
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/K141441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141441: Menntor X7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141441
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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