Cleared Traditional

K250285 - NEUROVENT-P (092946-003) (FDA 510(k) Clearance)

Also includes:
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

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250285 · Raumedic AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
210d
Days
Class 2
Risk

K250285 is an FDA 510(k) clearance for the NEUROVENT-P (092946-003). Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Raumedic AG (Helmbrechts, DE). The FDA issued a Cleared decision on August 29, 2025 after a review of 210 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Raumedic AG devices

Submission Details

510(k) Number K250285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2025
Decision Date August 29, 2025
Days to Decision 210 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 148d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 104
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