510(k) · Cleared
ClearedBis Interface for Vitalogik Patient Monitors
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 Dec 16, 2008 as substantially equivalent to K071899 (Mennen Medical, Ltd., 2007) after a 63-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Dec 16, 2008
- Review
- 63 days
- Class
- Class II
- Product code
- OLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060900 (2006). No later device cites it as a predicate yet.
- Root · 2 generations backK060900 Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and…Spacelabs Medical, Inc. · 2006
- 1 generation backK071899 Bis Module for Envoy Patient MonitorMennen Medical, Ltd. · 2007
- This deviceK083063 Bis Interface for Vitalogik Patient MonitorsMennen Medical, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060900 | Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and… | Spacelabs Medical, Inc. | 2006 | — |
| −1 | K071899 | Bis Module for Envoy Patient Monitor | Mennen Medical, Ltd. | 2007 | — |
| 0 (this device) | K083063 | Bis Interface for Vitalogik Patient Monitors | Mennen Medical, Ltd. | 2008 | — |
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 |
|---|---|---|---|
| * | K071899 | Bis Module for Envoy Patient MonitorSummary page 1…Nov, 2007 K073140 BIS module of the Envoy monitor- The predicate device. The addition of the BIS Module to the Envoy Patient Monitor was cleared by the FDA at Oct. 2007 K071899 Intended Use of the Vital.ogik Patient Monitor The VitaLogik Monitor is a physiological patient monitor intended to be used for… | 2007 |
| † | K040183 | BISX | 2004 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All OLW devicesOLW Index-Generating Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
VitaLogik series is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik series can monitor ECG/heart rate, invasive blood pressure channels, temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the VitaLogik series to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include…
Read the full statement (269 words)
VitaLogik series is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik series can monitor ECG/heart rate, invasive blood pressure channels, temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the VitaLogik series 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 VitaLogik 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
% Critical Care Patients
% Cardiac Step-down Telemetry Units
% Emergency Departments
% Intra-operative (Anesthesia) Monitoring
% Post Anesthesia Care
The Mennen Medical VitaLogik BIS interface 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, & 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.
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/K083063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083063: Bis Interface for Vitalogik Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083063
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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