510(k) · Cleared
ClearedNeurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003); Neurovent-Ifd-S (091678-003); Neurovent-P-Temp (094268-003); Neurovent-Temp (094278-003); Neurovent-Temp-Ifd-R (095327-003); Neurovent-Temp-Ifd-S (094288-003); Neurovent-Pto (095008-003); Neurovent-Pto 2L (095108-003); Neurovent-PX (091580-003); Bolt-Drill Kit CH5 (091888-003); Bolt-Drill Kit CH9 (091898-003); Bolt-Drill Kit Pto (092380-003); Bolt-Drill Kit VP 16 (092969-003); Bolt Kit CH5 (091868-003); Bol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raumedic AG · GWM Device, Monitoring, Intracranial Pressure
Cleared on Aug 29, 2025 as substantially equivalent to K103206 (Raumedic AG, 2011) and 4 other predicates after a 210-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Aug 29, 2025
- Review
- 210 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K914479 (1994). 20 ancestors in all, the oldest K813459 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 5 generations backK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
- 4 generations backK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- 3 generations backK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- 2 generations backK120252 Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
- 1 generation backK130529 Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013
- This deviceK250285 Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R…Raumedic AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −5 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
| −4 | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| −3 | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| −2 | K120252 | Raumedic-Icp-Temp-Monitoring-System | Raumedic AG | 2012 | — |
| −1 | K130529 | Raumedic-Pto-Monitoring-System | Raumedic AG | 2013 | — |
| 0 (this device) | K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R… | Raumedic AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2016 | 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 12.9 · 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? (5)
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 |
|---|---|---|---|
| * | K103206 | Raumedic- Icp-Monitoring SystemSummary page 6…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K103206 RAUMEDIC@ ICP-MONITORING-SYSTEM IGWM I K112017 I RAUMEDIC@ ICP-… | 2011 |
| * | K112017 | Raumedic Icp Monitoring SystemSummary page 6…de Name (Primary Predicate is listed first) Product Code I K103206 RAUMEDIC@ ICP-MONITORING-SYSTEM IGWM I K112017 I RAUMEDIC@ ICP-MONITORING-SYSTEM ventricular IGWM K120252… | 2011 |
| * | K120252 | Raumedic-Icp-Temp-Monitoring-SystemSummary page 7…ING-SYSTEM IGWM I K112017 I RAUMEDIC@ ICP-MONITORING-SYSTEM ventricular IGWM K120252 RAUMEDIC@ ICP-TEMP-MONITORING-SYSTEM GWM K130529… | 2012 |
| * | K130529 | Raumedic-Pto-Monitoring-SystemSummary page 7…IGWM K120252 RAUMEDIC@ ICP-TEMP-MONITORING-SYSTEM GWM K130529 RAUMEDIC@ PTO-MONITORING-SYSTEM GWM K153347… | 2013 |
| * | K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman…Summary page 7…GWM K130529 RAUMEDIC@ PTO-MONITORING-SYSTEM GWM K153347 Codman® Codman Microsensor Basic Kit GWM Device Description… | 2016 |
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 31 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 7 of the 20 ancestors have a recall of any class.
- 3 other devices also cite its predicate K103206.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
The NEUROVENT is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). The NEUROVENT IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). The NEUROVENT IFD-R is indicated for use in ventricular pressure monitoring…
Read the full statement (517 words)
The NEUROVENT is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).
The NEUROVENT IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).
The NEUROVENT IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).
The NEUROVENT-P is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).
The NEUROVENT-PX is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).
The NEUROVENT-P-TEMP is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.
The NEUROVENT-TEMP is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.
The NEUROVENT-TEMP IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.
The NEUROVENT-TEMP-IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.
The NEUROVENT-PTO is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.
The NEUROVENT-PTO-2L is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.
The BOLT(-DRILL) KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.
The DRILL KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.
The Tunneling KITs are indicated to provide a cranial access for catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250285: Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003); Neurovent-Ifd-S (091678-003); Neurovent-P-Temp (094268-003); Neurovent-Temp (094278-003); Neurovent-Temp-Ifd-R (095327-003); Neurovent-Temp-Ifd-S (094288-003); Neurovent-Pto (095008-003); Neurovent-Pto 2L (095108-003); Neurovent-PX (091580-003); Bolt-Drill Kit CH5 (091888-003); Bolt-Drill Kit CH9 (091898-003); Bolt-Drill Kit Pto (092380-003); Bolt-Drill Kit VP 16 (092969-003); Bolt Kit CH5 (091868-003); Bol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250285
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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