Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GWM — Predicate Candidate Screening

105 FDA 510(k) clearances under this product code; the 50 most recent screened below.

87 daysmedian FDA review time

319 days90th percentile

105clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252241	Pressio 3 Multi-parameter Neuromonitoring System	Sophysa	2026-04-10	267	0
K250285	NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-	Raumedic AG	2025-08-29	210	0
K240821	B4C System - Addition of new sensor model (BcSs-PICNIW-2000)	Braincare Desenvolvimento E Inovação Tecnológica S.A.	2024-07-18	115	0
K232890	CereLink ICP Monitor (826820), CereLink ICP Extension Cable	Integra Lifesciences Production Corporation	2024-02-04	139	1
K201989	B4C System	Braincare Desenvolvimento E Inovacao Tecnologica S.A.	2021-10-08	448	0
K210993	CereLink ICP Monitor	Integra Lifesciences Production Corporation	2021-04-30	28	2
K201118	Exacta External Drainage and Monitoring System, Exacta Pole	Medtronic, Inc.	2020-05-26	29	0
K200630	Medtronic External Drainage and Monitoring System, Medtronic	Medtronic, Inc.	2020-04-09	30	0
K200456	Becker External Drainage and Monitoring System	Medtronic, Inc.	2020-03-26	30	2
K182073	BcSs-PICNI-2000 Sensor	Braincare Desenvolvimento E Inovacao Tecnologica S.A.	2019-10-17	442	0
K183406	CereLink ICP Monitor, CereLink ICP Extension Cable	Integra Lifesciences Corp.	2019-01-11	32	0
K172209	AURA ICP MONITORING SYSTEM	Branchpoint Technologies, Inc.	2018-05-18	298	0
K173192	CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Sku	Codman & Shurtleff, Inc.	2017-11-08	37	1
K171666	MPR2 logO DATALOGGER	Raumedic AG	2017-07-06	31	0
K162108	Pressio 2 ICP Monitoring System	Sophysa SA	2017-04-17	262	3
K161010	HICP200 Patient/Monitor Interconnect Cable	Innerspace Neuro Solutions, Inc.	2016-10-20	192	0
K153347	Codman Microsensor Basic Kit, Codman Microsensor Plastic Sku	Codman & Shurtleff, Inc.	2016-08-19	273	1
K152670	DirectLink ICP Module, DirectLink ICP Extension Cable, Patie	Medos International SARL	2016-01-22	127	0
K141869	QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT	Hemedex Incorporated	2014-10-10	91	0
K133754	INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITO	Integra LifeSciences Corporation	2014-03-06	87	0
K130529	RAUMEDIC-PTO-MONITORING-SYSTEM	Raumedic AG	2013-10-25	238	0
K131184	INTEGRA LICOX PTO2 MONITOR	Integra Lifesciences Corp.	2013-08-30	127	5
K121573	INTEGRA CAMINO ICP MONITOR	Intrgra Lifesciences Corporation	2012-09-10	104	3
K121159	INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITO	Integra Lifescience Corportation	2012-07-20	95	0
K113088	HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD	Innerspace, Inc.	2012-05-02	196	0
K120252	RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM	Raumedic AG	2012-04-11	75	0
K112017	RAUMEDIC ICP MONITORING SYSTEM	Raumedic AG	2011-10-11	89	0
K103206	RAUMEDIC- ICP-MONITORING SYSTEM	Raumedic AG	2011-03-04	123	0
K102077	MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM	Cma Microdialysis AB	2011-01-14	175	0
K102875	CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMIN	Integra LifeSciences Corporation	2010-12-20	80	3
K101133	SENSOMETRICS SOFTWARE	Dpcom AS	2010-11-18	210	0
K083378	SYNERGY	Innerspace, Inc.	2009-09-29	319	0
K071984	MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM	Cma Microdialysis AB	2008-06-27	344	0
K072379	MPS OXIPORT AND MPS OXIPORT PLUS	Innerspace, Inc.	2008-04-29	249	0
K071505	MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRA	Integra LifeSciences Corporation	2007-08-06	66	1
K062584	PRESSIO ICP MONITORING SYSTEM	Sophysa SA	2007-07-05	307	2
K061640	INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM	Integra LifeSciences Corporation	2006-07-27	45	0
K053244	LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT	Integra Lifesciences Corp.	2006-05-10	170	1
K060554	CMA CEREBRAL TISSUE MONITORING SYSTEM	Cma Microdialysis AB	2006-05-02	62	0
K051599	NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSUR	Neurorecovery, Inc.	2005-07-19	33	0
K050702	NEUROSYSTEMS 1TM MONITOR	Neurosystems, LLC	2005-05-17	60	0
K050720	NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MO	Integra Neurosciences	2005-05-11	51	1
K041838	MPS (OR MPS-T)	Innerspace, Inc.	2005-03-01	237	0
K042728	CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM	Novus Monitoring, Ltd.	2004-10-22	21	0
K040235	LICOX PMO BRAIN MONITORING SYSTEM	Integra LifeSciences Corporation	2004-04-20	78	12
K032337	HEMEDEX CRANIAL BOLT MODELS, 3601, 3602	Hemedex Incorporated	2003-10-21	84	0
K031086	CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1	Integra Neurosciences	2003-05-14	37	0
K022638	NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT	Neurorecovery, Inc.	2002-10-31	84	0
K020285	CMA CEREBRAL TISSUE MONITORING SYSTEM	Cma Microdialysis AB	2002-10-23	268	0
K013705	ACT III VENTRICULAR CATHETER	Innerspace, Inc.	2002-09-09	305	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda