Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HLX — Predicate Candidate Screening

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

88 daysmedian FDA review time

179 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K003442	MODIFICATION TO EDI VERIS SYSTEM	Electro-Diagnostic Imaging, Inc.	2001-05-04	179
K983983	EDI VERIS SYSTEM	Electro-Diagnostic Imaging, Inc.	1999-02-03	86
K925741	CLARUS ENDOSCOPIC HOOK KNIFE	Clarus Medical Systems, Inc.	1993-08-24	284
K914393	RETINA TESTER	Retina Tester	1992-03-02	153
K914163	SCOPTOPIC SENSITIVITY TEST-1[SST-1]	Lkc Technologies, Inc.	1991-10-25	38
K873990	IRAS EDS INTERFEROMETRIC STIMULATOR	Randwal Instrument Co., Inc.	1988-02-05	127
K853812	PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)	Biosan Laboratories, Inc.	1985-11-01	50
K833446	DOWNING SPECTRAL ILLUMINATOR	Vision Health Technology	1984-03-12	159
K832762	MILLER/NADLER GLARE TESTER	Titmus Optical, Inc.	1983-09-29	44
K831231	LED GOGGLES	Cadwell Laboratories, Inc.	1983-05-16	31
K830770	CONTRAST SENSITIVITY EQUIPMENT	Cadwell Laboratories, Inc.	1983-04-28	48
K822923	5012 PARABOLIC STIMULATOR	Life-Tech Intl., Inc.	1982-12-28	88
K822922	5011 GANZFELD STIMULATOR	Life-Tech Intl., Inc.	1982-12-28	88
K822915	5031 BRIGHT FLASH STIMULATOR	Life-Tech Intl., Inc.	1982-12-28	88
K822919	5010 VISUSTIM	Life-Tech Intl., Inc.	1982-12-28	88
K812331	VTS-1000 VISUAL TESTING SYSTEM	Nicolet Biomedical Instruments	1981-11-16	90
K810699	PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM	Visidyne Corp.	1981-06-09	85
K790637	COMPUTERIZED ELECTRO-OCULOGRAPH	Potomac Medical System	1979-08-28	148

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