510(k) · Cleared
ClearedModification to Ensemble Central Station 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 Aug 12, 1998 as substantially equivalent to K974510 (Mennen Medical, Inc., 1998) and 1 other predicate after a 9-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Aug 12, 1998
- Review
- 9 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911616 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911616 | Horizon XL | Mennen Medical, Inc. | 1991 | — |
| −1 | K974510 | Envoy Patient Monitor | Mennen Medical, Inc. | 1998 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K974510 | Envoy Patient MonitorSummary page 1…anel: Class III 74 DSI Anesthesiology and Respiratory/Cardiology Substantial Equivalency Information: The following tables summarize data on the Mennen Medical ENVOY (K974510) and the Mennen Medical Medical HORIZON XL (K911616 ) Patient monitors. The Ensemble Central Station is able to display the sign… | 1998 |
| * | K911616 | Horizon XLSummary page 1…ry/Cardiology Substantial Equivalency Information: The following tables summarize data on the Mennen Medical ENVOY (K974510) and the Mennen Medical Medical HORIZON XL (K911616 ) Patient monitors. The Ensemble Central Station is able to display the signals that are transmitted to it by the patient monitor… | 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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 6.8 years on median.
- None of the 3 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.
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?
ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.
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/K982697 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982697: Modification to Ensemble Central Station Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982697
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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