510(k) · Cleared
Recalled · 2005Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models NS-P, NS-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences · GWM Device, Monitoring, Intracranial Pressure
Cleared on May 11, 2005 as substantially equivalent to K013930 (Novus Monitoring, Ltd., 2002) after a 51-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it. It has been recalled once.
- Decided
- May 11, 2005
- Review
- 51 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K875179 (1988). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 3 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 2 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 1 generation backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- This deviceK050720 Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring…Integra Neurosciences · 2005
- Descendant · cites it directly · 0 of its ownK071505 Modification to Neurosensor Cerebral Blood Flow and Intracranial…Integra LifeSciences Corporation · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K071505Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring…Integra LifeSciences Corporation · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −3 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −2 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −1 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| 0 (this device) | K050720 | Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring… | Integra Neurosciences | 2005 | — |
| +1 | K071505 | Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure… | Integra LifeSciences Corporation | 2007 | 1 |
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 |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K013930 | NeurosensorSummary page 1…onitoring Si's tern Unmodified NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring System, 510(k) K(013930 Common Name: Cerebral Blood Rlow and Intracranial Pressure Monitoring System… | 2002 |
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 |
|---|---|---|---|
| K071505 | Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring… | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 8, 2005 | Not classified | Z-0339-06 | Other | Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K071505 (Integra LifeSciences Corporation, 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K013930.
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® 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/K050720 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050720: Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models NS-P, NS-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050720
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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