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

GWS — Predicate Candidate Screening

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

85 daysmedian FDA review time

273 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K974718	PERSYST PRISM	Persyst Development Corp.	1998-03-09	82
K925735	EEG ANALYZER	Bio-Scan, Inc.	1993-12-03	385
K912938	RHYTHM	Stellate Systems	1991-07-30	25
K894629	NICOLET BEAM II SYSTEM	Nicolet Instrument Corp.	1990-03-09	228
K871931	ISTAT SOFTWARE	Neuroscience, Inc.	1987-10-13	147
K871480	STD-228 SPECTRAL TREND DISPLAY	Grass-Telefactor Product Group	1987-05-01	17
K854662	OEE_7102 EEG/TREND MONITOR	Nihon Kohden America, Inc.	1986-08-20	273
K860829	CNS 4/8 AND CT 48.1 SOFTWARE	Cns, Inc.	1986-05-29	85
K854160	CNS-16 & LTM 1.0 SOFTWARE	Cns, Inc.	1986-01-10	91
K850430	NEUROSCIENCE MAP-10 EEG	Neuroscience, Inc.	1985-07-17	163
K844481	NEUROLAB II	Teca, Inc.	1985-05-20	182
K844015	CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE	Cns, Inc.	1984-12-17	66
K803233	MEUROMETRICS MONITOR	Dade Medical, Inc.	1981-01-12	21
K800452	NEUROMETRICS MONITOR	Neurometrics	1980-04-02	34
K800001	MINI-CEARS COMPUTER (MODEL 1)	Bik Foundation, Inc.	1980-01-31	29

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