GWM · Device, Monitoring, Intracranial Pressure

Device class

Class II

Regulation 882.1620

Total clearances

2020-03-26 → 2026-04-10

Last 12 months

Unique sponsors

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.1620

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Medtronic, Inc.	3	0	2020-05-26
Integra Lifesciences Production Corporation	2	0	2024-02-04
Braincare Desenvolvimento E Inovação Tecnológica S.A.	1	0	2024-07-18
Raumedic AG	1	1	2025-08-29
Sophysa	1	1	2026-04-10
Braincare Desenvolvimento E Inovacao Tecnologica S.A.	1	0	2021-10-08

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
61107	CPT	—	Medium	CPT code for intracranial pressure monitoring device insertion and management
95812	CPT	—	Medium	CPT code for electroencephalography (EEG) with intracranial monitoring in critical care settings

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-10	K252241	Sophysa	Pressio 3 Multi-parameter Neuromonitoring System
2025-08-29	K250285	Raumedic AG	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
2024-07-18	K240821	Braincare Desenvolvimento E Inovação Tecnológica S.A.	B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
2024-02-04	K232890	Integra Lifesciences Production Corporation	CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
2021-10-08	K201989	Braincare Desenvolvimento E Inovacao Tecnologica S.A.	B4C System
2021-04-30	K210993	Integra Lifesciences Production Corporation	CereLink ICP Monitor
2020-05-26	K201118	Medtronic, Inc.	Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
2020-04-09	K200630	Medtronic, Inc.	Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
2020-03-26	K200456	Medtronic, Inc.	Becker External Drainage and Monitoring System