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

GWK — Predicate Candidate Screening

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

68 daysmedian FDA review time

197 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K060919	ACTICAL	Respironics, Inc.	2006-09-22	171	1
K061870	VITALSENSE XHR	Respironics, Inc.	2006-08-31	59	0
K052489	ACTIHEART	Respironics, Inc.	2005-09-27	15	0
K991045	MINI-LOGGER SERIES 2000	Mini-Mitter Co., Inc.	1999-09-21	176	0
K905594	NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300	Nihon Kohden America, Inc.	1991-06-28	197	0
K904328	VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM	Telediagnostic Systems, Inc.	1991-06-18	271	0
K896164	ASC-954 INTEGRATOR AMPLIFIER	Astro-Med, Inc.	1990-01-22	90	0
K882599	NICOLET BRAINLAB SYSTEM	Nicolet Instrument Corp.	1988-10-19	117	0
K872290	BIO-LOGIC BANKER	Bio-Logic Systems Corp.	1987-10-06	112	0
K870381	DD-VCR-64	Grass-Telefactor Product Group	1987-03-25	55	0
K860914	ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV	Bio-Feedback Systems, Inc.	1986-06-06	87	0
K843598	BRAIN FUNCTION MAPPING OPTION FOR PATHF	Nicolet Biomedical Instruments	1985-04-11	211	0
K841497	NEUROPACK 8 MEE 4108	Nihon Kohden America, Inc.	1984-06-07	58	0
K841110	NEUROTRAC	Interspec, Inc.	1984-04-30	76	0
K833298	AUDIT V AX 135	Axonics, Inc.	1983-12-01	69	0
K830191	NEURO DIAGNOSTICS MODEL FCR	Neurodiagnostics, Inc.	1983-02-18	29	0
K803226	EVOKED RESPONSE STIMULATORS	Bio-Logic Systems Corp.	1981-02-05	48	0
K801604	PATHFINDER ELECTRODIAGNOSTIC SYSTEM	Nicolet Biomedical Instruments	1980-08-04	21	0
K801670	NDI-IKE EMG	Neurodiagnostics, Inc.	1980-08-04	13	0
K781290	SIGNAL AVERAGER MODEL 4202	Princeton Applied Research Corp.	1978-09-15	50	0
K780538	AUDIO MONITOR-MODEL 8309	Life-Tech Instruments, Inc.	1978-04-19	16	0
K771742	EVOKED RESPONSE SYS., MODEL 10	Grass Instrument Co.	1977-11-22	68	0
K770782	FIBERSCOPIC SCOPE RECORDER SYSTEM	Elmed, Inc.	1977-05-06	4	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