# 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

- Pathway: 510(k) (Traditional)
- Applicant: Raumedic AG
- Decided: Aug 29, 2025 after 210 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914479 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103206: Raumedic- Icp-Monitoring System, Raumedic AG (2011) Summary page 6.
- K112017: Raumedic Icp Monitoring System, Raumedic AG (2011) Summary page 6.
- K120252: Raumedic-Icp-Temp-Monitoring-System, Raumedic AG (2012) Summary page 7.
- K130529: Raumedic-Pto-Monitoring-System, Raumedic AG (2013) Summary page 7.
- K153347: Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit, Codman & Shurtleff, Inc. (2016) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K250285
Methodology: https://510kreport.com/methodology