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

HLQ — Predicate Candidate Screening

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

75 daysmedian FDA review time

208 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days
K003299	OPD-SCAN, MODELS ARK-10000 AND ARK-9000	Nidek Co., Ltd.	2001-03-09	140
K973756	EYE SYS VISTA	Eyesys Technologies, Inc.	1997-11-13	42
K964290	EYECHEK	Reichert Ophthalmic Instruments, Div. Leica, Inc.	1997-01-09	73
K945382	TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER	Expertech Assoc., Inc.	1995-01-31	90
K944207	TOPOGRAPHIC MODELING SYSTEM 2 TMS-2	Computed Anatomy, Inc.	1994-12-07	100
K944616	KERATRON CORNEAL TOPOGRAPHER	Alliance Medical Marketinig	1994-11-22	63
K940647	ORBSCAN(TM) KERATOMETER	Orbtek, Inc.	1994-07-06	141
K933556	EH-270 CORNEAL TOPOGRAPHER	Visioptic, Inc.	1993-11-02	104
K923435	CORNEAL TOPOGRAPHY SYSTEM	Par Microsystems Corp.	1993-02-16	218
K922253	KERATOREF L60	Luneau Ophtalmologie SA	1992-06-19	49
K912740	ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)	Visionary Systems, Inc.	1991-12-30	192
K913022	CCI VIDEOKERATOSCOPE/COMPARATOR	Cci	1991-10-09	92
K912130	TBD KERATOSCOPE	Alcon Laboratories	1991-08-09	87
K895741	CLAS PHOTOKERATOSCOPE	Kera-Metrics Corp.	1990-07-11	288
K902012	VKS-1 VIDEO KERATOSCOPE	Computed Anatomy, Inc.	1990-06-22	50
K901009	MODEL 2000 INTRAOPERATIVE CORNEASCOPE	Kera Corp.	1990-05-30	86
K901363	TOPOGRAPHIC MODELING SYSTEM	Computed Anatomy, Inc.	1990-05-25	63
K895475	CANON AUTO REF-KERATOMETER RK-2	Canon USA, Inc.	1989-10-31	50
K890687	ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER	Optimed, Inc.	1989-09-05	208
K871936	CANON SURGICAL AUTO KERATOMETER SK-1	Canon USA, Inc.	1987-06-19	32
K871479	VIDEOSCAN (TM)	Kera Corp.	1987-05-22	38
K862137	NIDEK KM-1000 SURGICAL KERATOMETER	Nidek, Inc.	1986-07-23	49
K861063	NIDEK KM-800 AUTO KERATOMETER	Nidek, Inc.	1986-04-04	15
K853668	ORC ORACLE	Optical Radiation Corp.	1985-10-15	42
K853723	ZEISS OPERATING KERATOMETER	Carl Zeiss, Inc.	1985-10-15	40
K850665	CORNEASCOPE MODEL 1200	Kera Corp.	1985-03-20	28
K841765	WOODLYN STANDARD SLIT LAMP HSSL-ST	Woodlyn, Inc.	1984-08-07	102
K831084	SUN PHOTO-KERATOSCOPE	Nidek, Inc.	1983-06-30	87
K781994	AUTOKERATOMETER, INSTRUMENT	Zeiss Humphrey System	1979-02-12	75

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