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

Nicolet Biomedical Instruments — Predicate Candidate Screening

26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

55 daysmedian FDA review time

127 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K880573	MODIFIED NICOLET VIKING SYSTEM	Nicolet Biomedical Instruments	1988-03-22	41
K873736	NICOLET DIGITAL TWO PIECE HEARING AID	Nicolet Biomedical Instruments	1987-12-08	84
K873964	NICOLET DISPOSABLE PRASS PROBE	Nicolet Biomedical Instruments	1987-11-20	52
K873535	NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM	Nicolet Biomedical Instruments	1987-10-26	55
K871678	NICOLET AMP 6R11 SYSTEM	Nicolet Biomedical Instruments	1987-07-16	79
K862592	PHOENIX SYSTEM SEVEN.	Nicolet Biomedical Instruments	1986-09-16	70
K851190	NYSTAGMOGRAPH EOG/ENG ANALYSES	Nicolet Biomedical Instruments	1985-11-27	246
K850259	ELECTROENCEPHALOGRAPH EEG	Nicolet Biomedical Instruments	1985-04-11	79
K850107	CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE	Nicolet Biomedical Instruments	1985-04-11	91
K843598	BRAIN FUNCTION MAPPING OPTION FOR PATHF	Nicolet Biomedical Instruments	1985-04-11	211
K850108	EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG	Nicolet Biomedical Instruments	1985-04-11	91
K842956	NICOLET VIKING	Nicolet Biomedical Instruments	1984-08-03	7
K842611	CA2000	Nicolet Biomedical Instruments	1984-07-20	15
K842612	COMPACT AUDITORY	Nicolet Biomedical Instruments	1984-07-20	15
K842613	COMPACT VISUAL	Nicolet Biomedical Instruments	1984-07-20	15
K831896	COMPACT FOUR	Nicolet Biomedical Instruments	1983-07-28	44
K830702	NICOLET EMG SATELLITE	Nicolet Biomedical Instruments	1983-07-12	127
K830579	MULTI-SIGNAL AUDITORY STIMULATOR SM700	Nicolet Biomedical Instruments	1983-03-08	13
K822215	NIC OPTRONICS CS-2000	Nicolet Biomedical Instruments	1982-08-31	36
K813399	ERG-JET ELECTRODE	Nicolet Biomedical Instruments	1982-01-22	49
K812331	VTS-1000 VISUAL TESTING SYSTEM	Nicolet Biomedical Instruments	1981-11-16	90
K802149	TM-5 INTRACRANIAL PRESSURE MONITOR	Nicolet Biomedical Instruments	1980-11-12	65
K801604	PATHFINDER ELECTRODIAGNOSTIC SYSTEM	Nicolet Biomedical Instruments	1980-08-04	21
K792466	NIC-200 VENTRICULAR FUNCTION ANALYZER	Nicolet Biomedical Instruments	1980-01-24	52
K790570	STIMULATOR, NIC-106 VISUAL	Nicolet Biomedical Instruments	1979-05-23	61
K771449	ARTEOIAL TONOMETER ML-105	Nicolet Biomedical Instruments	1977-09-06	35

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