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, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 26, 2004 as substantially equivalent to K011784 (Mennen Medical, Ltd., 2001) after a 356-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Feb 26, 2004
- Review
- 356 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001120 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001120 Envoy Patient MonitorMennen Medical, Ltd. · 2001
- 1 generation backK011784 Modification to Envoy Patient MonitorMennen Medical, Ltd. · 2001
- This deviceK030722 Envoy Patient MonitorMennen Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK141441 Menntor X7Mennen Medical, Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K141441Menntor X7Mennen Medical, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001120 | Envoy Patient Monitor | Mennen Medical, Ltd. | 2001 | — |
| −1 | K011784 | Modification to Envoy Patient Monitor | Mennen Medical, Ltd. | 2001 | — |
| 0 (this device) | K030722 | Envoy Patient Monitor | Mennen Medical, Inc. | 2004 | — |
| +1 | K141441 | Menntor X7 | Mennen Medical, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K011784 | Modification to Envoy Patient MonitorSummary page 5…neral Requirement for Safety Collateral Standard: Electromagnetic compatibility - Requirements and tests. Predicate Device: METEOR Respiratory Mechanics Monitor(s) - K01 1784. Device Description - Envoy Patient Monitor: The Envoy is a multiparameter physiological patient monitor consisting of a mai… | 2001 |
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 |
|---|---|---|---|
| K141441 | Menntor X7 | 2015 | 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K141441 (Mennen Medical, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K011784.
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 Envoy is 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, etCO2 and Spirometry. This effectively allows the Envoy to monitor a
wide-range of adult, pediatric and neonatal patient conditions, in many different
areas of the hospital.
The Envoy also includes a spirometer intended for continuous monitoring of adult
and pediatric patients with tidal volumes greater than 100mL. Functions include
display of multiparameter waveforms, vital signs, and status messages.
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/K030722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030722: Envoy Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030722
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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