510(k) · Cleared
ClearedEnvoy Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Ltd. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on May 10, 2004 as substantially equivalent to K910945 (Mennen Medical, Inc., 1991) after a 504-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- May 10, 2004
- Review
- 504 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910945 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910945 Horizon 2000 Eeg Monitoring OptionMennen Medical, Inc. · 1991
- This deviceK024245 Envoy Patient MonitorMennen Medical, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910945 | Horizon 2000 Eeg Monitoring Option | Mennen Medical, Inc. | 1991 | — |
| 0 (this device) | K024245 | Envoy Patient Monitor | Mennen Medical, Ltd. | 2004 | — |
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 OMC? 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 OMC device
- #1 K251550 NX01 (NX01)score 13.1 · 10 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 |
|---|---|---|---|
| * | K910945 | Horizon 2000 Eeg Monitoring OptionSummary page 2…sts. *IEC 60601-2-26: Particular Requirements for the safety of electroencephalographs Predicate Device: EEG module of the Mennen Medical Horizon 2000 patient monitor (K910945) Page 2 of 6 Food and Drug Administration ENVOY Patient Monitor: $10(k) for new EEQ module Intended Use and Dev… | 1991 |
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?
- Its one ancestor has no recall.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMC
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMC
No recall names OMC since 2007.
Adverse event reports per year · OMC
2in 2025
MAUDE reports naming product code OMC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 3 | 56 | 0 | 2 |
| 2025 | 3 | 172 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Envoy s intended for use as a multiparameter monitoring system. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, E{CO2 and EEG, The EEG module is not intended for use on infants. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, In many different areas of the hospital. Functions…
Read the full statement (129 words)
The Envoy s intended for use as a multiparameter monitoring system.
The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, E{CO2 and EEG,
The EEG module is not intended for use on infants.
This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, In many different areas of the hospital. Functions include display of multiparameter waveforms, vital slgns, alarm & status messages.
The Mennen Medical Envoy is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following.are examples of intended clinical applications:
« Critical Care Patients
o Cardiac Step-down/Telemetry Units
+ Emergency Departments
« Intra-operative (Anesthesia) Monitoring
» Post Anesthesia Care
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/K024245 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024245: Envoy Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024245
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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