510(k) · Cleared
Recalled · 2008Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure 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 Aug 6, 2007 as substantially equivalent to K050720 (Integra Neurosciences, 2005) after a 66-day review. Its family tree reaches back 5 generations to 1988. It has been recalled once.
- Decided
- Aug 6, 2007
- Review
- 66 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K875179 (1988). 9 ancestors in all. No later device cites it as a predicate yet.
- 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 backK050720 Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring…Integra Neurosciences · 2005 · Recalled
- This deviceK071505 Modification to Neurosensor Cerebral Blood Flow and Intracranial…Integra LifeSciences Corporation · 2007
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 | K050720 | Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring… | Integra Neurosciences | 2005 | 1 |
| 0 (this device) | K071505 | Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure… | Integra LifeSciences Corporation | 2007 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K050720 | Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models…Summary page 1…substantially equivalent in function and intended use to the NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System previously cleared under 510(k) K050720 on 5/11/05. Testing was performed by Integra NeuroSciences, San Diego, CA, Integra NeuroSciences, Andover,UK and GemSoft, Inc in… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2008 | Not classified | Z-1191-2008 | Process design | Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 9 ancestors have a recall of any class.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System, is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071505 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071505: Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071505
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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