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. · DSI Detector And Alarm, Arrhythmia
Cleared on Apr 14, 1998 as substantially equivalent to K911616 (Mennen Medical, Inc., 1991) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Apr 14, 1998
- Review
- 134 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911616 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K982697Modification to Ensemble Central Station MonitorMennen Medical, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911616 | Horizon XL | Mennen Medical, Inc. | 1991 | — |
| 0 (this device) | K974510 | Envoy Patient Monitor | Mennen Medical, Inc. | 1998 | — |
| +1 | K982697 | Modification to Ensemble Central Station Monitor | Mennen Medical, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K911616 | Horizon XLSummary page 1…omatic cycling indirect blood pressure monitoring [EC601-2-34 Requirements for Invasive Blood Pressure monitoring equipment Predicate Devices MENNEN MEDICAL HORIZON XL (K911616). HEWLETT-PACKARD M1175/26 A COMPONENT MONITORING SYSTME (K941811). Date Prepared: 30 October 1997 Food and Drug… | 1991 |
| * | K941811 | HP M1175A, M1176A, Component Monitoring SystemSummary page 1…irements for Invasive Blood Pressure monitoring equipment Predicate Devices MENNEN MEDICAL HORIZON XL (K911616). HEWLETT-PACKARD M1175/26 A COMPONENT MONITORING SYSTME (K941811). Date Prepared: 30 October 1997 Food and Drug Administration 30 October 1997 510(k) Summary, ENVOY Safety & Eff… | 1994 |
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 |
|---|---|---|---|
| K982697 | Modification to Ensemble Central Station Monitor | 1998 | 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 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?
The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, and Pulse Oximetry. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition.
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/K974510 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974510: 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/K974510
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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