510(k) · Cleared
ClearedModification to Envoy Patient Monitor
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 Aug 16, 2001 as substantially equivalent to K001120 (Mennen Medical, Ltd., 2001) after a 69-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Aug 16, 2001
- Review
- 69 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001120 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001120 Envoy Patient MonitorMennen Medical, Ltd. · 2001
- This deviceK011784 Modification to Envoy Patient MonitorMennen Medical, Ltd. · 2001
- Descendant · cites it directly · 1 of its ownK030722 Envoy Patient MonitorMennen Medical, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK141441 Menntor X7Mennen Medical, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK023798 Modification to Envoy Patient MonitorMennen Medical, Ltd. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001120 | Envoy Patient Monitor | Mennen Medical, Ltd. | 2001 | — |
| 0 (this device) | K011784 | Modification to Envoy Patient Monitor | Mennen Medical, Ltd. | 2001 | — |
| +1 | K030722 | Envoy Patient Monitor | Mennen Medical, Inc. | 2004 | — |
| +2 | K141441 | Menntor X7 | Mennen Medical, Ltd. | 2015 | — |
| +1 | K023798 | Modification to Envoy Patient Monitor | Mennen Medical, Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K001120 | Envoy Patient MonitorSummary page 2…Medical electrical equipment, Part 2, (1994) Requirements for safety of electrocardiograph monitoring equipment. Predicate Device MENNEN MEDICAL ENVOY PATIENT MONITOR (K001120). Device Description: Envoy Patient Monitor The Envoy is a multiparameter physiological patient monitor, capable of monitoring:… | 2001 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ENVOY is intended for use as a multiparameter physiological patient monitoring system. The ENVOY can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. 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…
Read the full statement (120 words)
ENVOY is intended for use as a multiparameter physiological patient monitoring system.
The ENVOY can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. 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 signs, 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:
o Critical Care Patients
« Cardiac Step-down/Telemetry Units
o 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/K011784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011784: Modification to Envoy Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011784
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026