510(k) · Cleared
ClearedBis Module for Envoy Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Ltd. · OLW Index-Generating Electroencephalograph Software
Cleared on Oct 22, 2007 as substantially equivalent to K060900 (Spacelabs Medical, Inc., 2006) after a 105-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Oct 22, 2007
- Review
- 105 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060900 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK060900 Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and…Spacelabs Medical, Inc. · 2006
- This deviceK071899 Bis Module for Envoy Patient MonitorMennen Medical, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK083063 Bis Interface for Vitalogik Patient MonitorsMennen Medical, Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K083063Bis Interface for Vitalogik Patient MonitorsMennen Medical, Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060900 | Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and… | Spacelabs Medical, Inc. | 2006 | — |
| 0 (this device) | K071899 | Bis Module for Envoy Patient Monitor | Mennen Medical, Ltd. | 2007 | — |
| +1 | K083063 | Bis Interface for Vitalogik Patient Monitors | Mennen Medical, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 OLW? 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 OLW device
- #1 K260880 SedLine Sedation Monitorscore 17.1 · 19 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 |
|---|---|---|---|
| * | K060900 | Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories…Summary page 1…r with the addition of BISx module. SPACELAB MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS - The predicate device. The SpaceLab monitor was cleared for marketing by the FDA (K060900) Intended Use of the Envoy Patient Monitor The ENVOY Monitor is a physiological patient monitor intended to be used for monitor… | 2006 |
| † | K040183 | BISX | 2004 |
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 |
|---|---|---|---|
| K083063 | Bis Interface for Vitalogik Patient Monitors | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K083063 (Mennen Medical, Ltd., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLW devicesOLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OLW
105in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLW
No recall names OLW since 2007.
Adverse event reports per year · OLW
73in 2025
MAUDE reports naming product code OLW, 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 | 3 | 105 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 93 |
| 2025 | 0 | — | 0 | 73 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vita) signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Neninvasive Blood Pressure, CO, Pulse Oximetry, and EtCO,. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is…
Read the full statement (260 words)
The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vita) signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Neninvasive Blood Pressure, CO, Pulse Oximetry, and EtCO,. 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.
The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.
In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.
The Intended Use of the Envoy monitor as indicated above is same as the Indications For Use.
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/K071899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071899: Bis Module for 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/K071899
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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