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

OLW — Predicate Candidate Screening

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

88 daysmedian FDA review time

353 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K260880	SedLine Sedation Monitor	Masimo Corporation	2026-07-10	115
K230693	BIS™ Advance Monitoring System	Covidien, LLC	2024-02-26	350
K213273	Brain Anesthesia Response Monitor (Bar Monitor)	Cortical Dynamics , Ltd.	2023-09-01	701
K203113	Masimo SedLine Sedation Monitor and Accessories	Masimo Corporation	2022-02-25	498
K202621	NeuroSENSE Monitoring System, Model NS-901	Neurowave Systems, Inc.	2021-08-05	329
K172890	SedLine Sedation Monitor	Masimo Corporation	2018-01-26	126
K150298	Entropy Module, E-ENTROPY-01	Ge Healthcare Filand OY	2015-11-12	279
K083063	BIS INTERFACE FOR VITALOGIK PATIENT MONITORS	Mennen Medical , Ltd.	2008-12-16	63
K061907	MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY	GE Healthcare	2008-03-27	631
K072286	BIS EEG VISTA MONITOR SYSTEM AND BISX	Aspect Medical Systems, Inc.	2007-11-20	96
K071899	BIS MODULE FOR ENVOY PATIENT MONITOR	Mennen Medical , Ltd.	2007-10-22	105
K062613	BIS EEG MONITOR VIEW	Aspect Medical Systems, Inc.	2007-06-18	286
K060900	SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91	Spacelabs Medical, Inc.	2006-06-23	81
K060997	SNAP II EEG MONITOR	Everest Biomedical Instruments Co.	2006-06-15	66
K052981	BIS EEG MONITOR, MODEL BISX4	Aspect Medical Systems, Inc.	2005-11-01	8
K052362	BIS EEG MONITOR, MODEL A-3000	Aspect Medical Systems, Inc.	2005-09-09	11
K051874	SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG E	Physiometrix, Inc.	2005-09-02	53
K052145	DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES	GE Healthcare	2005-08-23	15
K050835	DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES	GE Healthcare	2005-05-06	35
K042315	CEREBRAL STATE MONITOR - CSM	Danmeter A/S	2005-01-21	148
K033543	NARCOTREND, MODEL COMPACT 4.0	Mt Monitortechnik GmbH & Co. KG	2004-09-17	312
K040183	BISX	Aspect Medical Systems, Inc.	2004-02-25	29
K033999	SEDLINE WITH FRONTAL PSI	Physiometrix, Inc.	2004-02-06	44
K030267	EEG MONITOR WITH BIS, MODEL A-2000	Aspect Medical Systems, Inc.	2004-01-15	353
K031694	MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000	Aspect Medical Systems, Inc.	2003-08-29	88
K023459	DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES	Datex-Ohmeda	2003-01-13	90
K020671	PSA4000 EEG MONITOR WITH FRONTAL PSI	Physiometrix, Inc.	2002-10-04	217
K020218	SNAP EEG MONITOR	Nicolet Biomedical, Inc.	2002-04-22	90
K013389	DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES	Datex-Ohmeda	2002-01-10	90
K012466	BIS/EEG MODULE	General Electric Medical Systems Information Techn	2001-10-01	61
K011834	BIS ENGINE	Aspect Medical Systems, Inc.	2001-07-10	28
K010965	A-LINE AEP MONITOR	Alaris Medical Systems, Inc.	2001-06-27	86
K011534	EEG MIS MONITOR MODEL # A-2000; BIS ENGINE	Aspect Medical Systems, Inc.	2001-06-15	28
K003038	AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT	Agilent Technologies Deutschland GmbH	2000-12-15	77
K002837	BIS ENGINE	Aspect Medical Systems, Inc.	2000-09-19	7
K001069	MODEL 4000 EEG MONITOR WITH PSI (PSA4000)	Physiometrix, Inc.	2000-06-30	88
K974496	A-2000 EEG MONITOR WITH BIS	Aspect Medical Systems, Inc.	1998-02-06	70
K973596	SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODU	Spacelabs Medical, Inc.	1998-02-03	134
K963644	A-1000 EEG MONITOR AND A-1050 EEG MONITOR	Aspect Medical Systems, Inc.	1996-10-08	26

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