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-Dri

Q: What is the product code of K250285?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.

FDA 510(k) K250285 · Raumedic AG

Substantially Equivalent

510(k) numberK250285

Submission

Device name: 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-Dri
Applicant: Raumedic AG
Helmbrechts, DE
Received: January 31, 2025
Decision date: August 29, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GWM – Device, Monitoring, Intracranial Pressure
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1620
Specialty: Neurology

Other 510(k)s with product code GWM

510(k)	Device	Applicant	Decision
K252241	Pressio 3 Multi-parameter Neuromonitoring SystemGWM · Traditional	Sophysa	04/10/2026SE
K240821	B4C System - Addition of new sensor model (BcSs-PICNIW-2000)GWM · Traditional	Braincare Desenvolvimento E Inovação Tecnológica…	07/18/2024SE
K232890	CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM · Traditional	Integra Lifesciences Production Corporation	02/04/2024SE
K201989	B4C SystemGWM · Traditional	Braincare Desenvolvimento E Inovacao Tecnologica…	10/08/2021SE
K210993	CereLink ICP MonitorGWM · Special	Integra Lifesciences Production Corporation	04/30/2021SE
K201118	Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…GWM · Special	Medtronic, Inc.	05/26/2020SE
K200630	Medtronic External Drainage and Monitoring System, Medtronic External Drainage and…GWM · Special	Medtronic, Inc.	04/09/2020SE
K200456	Becker External Drainage and Monitoring SystemGWM · Special	Medtronic, Inc.	03/26/2020SE
K182073	BcSs-PICNI-2000 SensorGWM · Traditional	Braincare Desenvolvimento E Inovacao Tecnologica…	10/17/2019SE
K183406	CereLink ICP Monitor, CereLink ICP Extension CableGWM · Special	Integra Lifesciences Corp.	01/11/2019SE

More from Integra Lifesciences Corp.

510(k)	Device	Decision
K171666	MPR2 logO DATALOGGERGWM · Traditional	07/06/2017SE
K130529	Raumedic-Pto-Monitoring-SystemGWM · Traditional	10/25/2013SE
K120252	Raumedic-Icp-Temp-Monitoring-SystemGWM · Traditional	04/11/2012SE
K112017	Raumedic Icp Monitoring SystemGWM · Traditional	10/11/2011SE
K103206	Raumedic- Icp-Monitoring SystemGWM · Traditional	03/04/2011SE

Questions and answers

When was 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-Dri cleared by the FDA?

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-Dri (K250285) received a 510(k) decision of Substantially Equivalent on August 29, 2025, 210 days after the submission was received.

What is the product code of K250285?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.