510(k) · Cleared
ClearedIntegra Mobius Multi-Modality Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jul 27, 2006 as substantially equivalent to K050702 (Neurosystems, LLC, 2005) and 1 other predicate after a 45-day review. Its family tree reaches back 5 generations to 1988. 15 later devices descend from it.
- Decided
- Jul 27, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K875179 (1988). 21 ancestors in all, the oldest K813459 (1982). 15 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 4 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 3 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 2 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 1 generation backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- This deviceK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- Descendant · cites it directly · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 3 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK173366 NicoletOneNatus Neurology Incorporated · 2018
- Descendant · 4 generations on · 2 of its ownK213299 Wireless EEG SystemPascall Systems, Inc. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · cites it directly14descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 2 generations on7descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 3 generations on5descendants
- K173366NicoletOneNatus Neurology Incorporated · 2018 · 2 generations on3descendants
- K213299Wireless EEG SystemPascall Systems, Inc. · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −4 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −3 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −2 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −1 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| 0 (this device) | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| +1 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +2 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +3 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
| +2 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| +4 | K213299 | Wireless EEG System | Pascall Systems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GWM? 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 GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 13.0 · 7 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 |
|---|---|---|---|
| * | K050702 | Neurosystems 1TM MonitorSummary page 1…Substantial Equivalence: The Integra Mobius Tm Multi-Modality Monitoring System is substantially equivalent in function and intended use to the NeuroSystems 11TmMonitor (K050702) and Bravo System (K991 054). Device Description: The Integra Mobius Tm Multi-Modality Monitoring System is a neurological monito… | 2005 |
| * | K991054 | Bravo Multi-Modality SystemSummary page 1…e Integra Mobius Tm Multi-Modality Monitoring System is substantially equivalent in function and intended use to the NeuroSystems 11TmMonitor (K050702) and Bravo System (K991 054). Device Description: The Integra Mobius Tm Multi-Modality Monitoring System is a neurological monitoring system that records and… | 1999 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080217 | Component Neuromonitoring System | 2008 | 14 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K080217 (Moberg Research, Inc., 2008) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K050702.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, 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 | 2 | — | 0 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Integra MobiusTM Multi-Modality Monitoring System is intended as an adjunct monitor for displaying and recording parameters such as Intracranial Pressure (ICP), Intracranial Temperature (ICT), Cerebral Blood Flow (CBF), Cerebral Perfusion Pressure (CPP), Cerebrovascular Resistance (CVR), Partial Pressure Brain Tissue Oxygen (PbtO 2) and other parameters from primary source bedside monitors for the purpose of treating patients with neurological disorders.
The Integra MobiusTM System data is presented both continuously and as trends to be used in concert with other clinical parameters, not as the sole basis for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061640: Integra Mobius Multi-Modality Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061640
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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