510(k) · Cleared
ClearedNeurosensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novus Monitoring, Ltd. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Feb 20, 2002 as substantially equivalent to K914479 (Codman & Shurtleff, Inc., 1994) and 3 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1988. 22 later devices descend from it.
- Decided
- Feb 20, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K875179 (1988). 7 ancestors in all. 22 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 2 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 1 generation backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- This deviceK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- Descendant · cites it directly · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- Descendant · 2 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- Descendant · 3 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
- Descendant · 5 generations on · 5 of its ownK120485 Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa…Nihon Kohden America, Inc. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K050702Neurosystems 1TM MonitorNeurosystems, LLC · 2005 · cites it directly17descendants
- K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006 · 2 generations on15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 3 generations on14descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 4 generations on7descendants
- K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc. · 2012 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −2 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −1 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| 0 (this device) | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| +1 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| +2 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| +3 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +4 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
| +5 | K120485 | Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend… | Nihon Kohden America, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K914479 | Microsensor Intracranial Pressure TransducerSummary page 1…roduct Code DPW), respectively. 3 Predicate Devices "The components of the NeuroSensor™ system are substantially equivalent to the following legally marketed devices: K914479 Codman ICP monitoring system and Microsensor™ ICP transducer K896515 Vasamedics Model BPM2 Laser Doppler Perfusion Monitor ===… | 1994 |
| * | K896515 | Laserflo Blood Perfusion Monitor, Model BPM2Summary page 1…of the NeuroSensor™ system are substantially equivalent to the following legally marketed devices: K914479 Codman ICP monitoring system and Microsensor™ ICP transducer K896515 Vasamedics Model BPM2 Laser Doppler Perfusion Monitor Koi3a30 2{3 13 K961368 Vasamedics Trimflo™ parenchymal blo… | 1990 |
| * | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe KitSummary page 2…ces: K914479 Codman ICP monitoring system and Microsensor™ ICP transducer K896515 Vasamedics Model BPM2 Laser Doppler Perfusion Monitor Koi3a30 2{3 13 K961368 Vasamedics Trimflo™ parenchymal blood flow monitoring kit K974088 Codman Intracranial Bolt This statement is based on the subje… | 1996 |
| * | K974088 | Codman Intracranial BoltSummary page 2…nsducer K896515 Vasamedics Model BPM2 Laser Doppler Perfusion Monitor Koi3a30 2{3 13 K961368 Vasamedics Trimflo™ parenchymal blood flow monitoring kit K974088 Codman Intracranial Bolt This statement is based on the subject device’s similarity to the predicate devices in intended use, ma… | 1998 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K050702 (Neurosystems, LLC, 2005) has gone furthest, with 17 descendants of its own.
- 5 other devices also cite its predicate K914479.
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 NeuroSensor™ System is intended for use by a qualified neurosurgeon in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.
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/K013930 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013930: Neurosensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013930
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026