Cleared Traditional

K250285 - NEUROVENT-P (092946-003)

Also marketed or referenced as:
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

K250285 is an FDA 510(k) clearance for NEUROVENT-P (092946-003), manufactured by Raumedic AG. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 210-day FDA review.

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

FDA 510(k) Submission Details - K250285

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.

GWM Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K250285.
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