NEUROVENT-P (092946-003) +15 more— 510(k) K250285

Clearance details

Device name as filed

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

Applicant

Raumedic AG

Product code

Code GWM

Device class

Class 2

Regulation

21 CFR 882.1620

Advisory panel

Neurology

Date received

2025-01-31

Decision date

2025-08-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Helmbrechts, DE

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• K171666 — MPR2 logO DATALOGGER2017-07-06
• K130529 — RAUMEDIC-PTO-MONITORING-SYSTEM2013-10-25
• K120252 — RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM2012-04-11
• K112017 — RAUMEDIC ICP MONITORING SYSTEM2011-10-11
• K103206 — RAUMEDIC- ICP-MONITORING SYSTEM2011-03-04

Death

21

Injury

732

Malfunction

2,063

Other

1

Total

2,817

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →