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

HPT · Predicate Candidate Screening

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

81 daysmedian FDA review time

237 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days
K092187	MAIA, MODEL 1	Centervue S.P.A.	2010-05-27	310
K093213	GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER I	Carl Zeiss Meditec, Inc.	2010-03-12	150
K091579	FORESEE HOME	Notal Vision , Ltd.	2009-12-23	204
K063310	TRUEFIELD ANALYZER	Seeing Machines Limited	2007-08-02	273
K050350	THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER	Notal Vision, Inc.	2005-04-29	77
K023623	NOVAVISION, MODEL 2.0	Novavision, Inc.	2003-04-22	175
K971156	KASHA VISUAL FIELD SYSTEM	Kasha Software, Inc.	1997-05-28	61
K961090	AUTOMATIC VISUAL FIELD PLOTTER AP-125	Kowa Optimed, Inc.	1996-06-17	90
K954167	HUMPHREY FIELD ANALYZER (HFA II)	Carl Zeiss, Inc.	1995-11-24	80
K954037	FIELD TREND	Synemed, Inc.	1995-11-17	81
K943234	MS-30 AUTOMATIC PERIMETER	Marco Ophthalmic, Inc.	1994-07-27	21
K932258	OPTICOM M600	Clement Clarke, Inc.	1994-07-25	441
K930937	LD 400	Vismed, Inc.	1993-10-18	237
K922294	PERIKON PCL 90	Optikon Oftalmologia Spa	1993-01-28	258
K902878	MT-336 AUTOMATIC PERIMETER	Marco Technologies	1990-09-18	78
K884867	OPTIFIELD I AND II AUTOMATED PERIMETERS	Optimed, Inc.	1989-03-09	108
K883458	OPTIMED ADVANTAGE	Optimed, Inc.	1988-11-07	87
K881219	AUTOMATIC PERIMETER, AP-340	Kowa Optimed, Inc.	1988-05-03	42
K874336	PATTERN DISCRIMINATION PERIMETER	Lkc Technologies, Inc.	1988-01-12	82
K873122	TKS 4000 AUTO PERIMETER	Vismed, Inc.	1987-11-02	84
K870120	DIGILAB MODEL 1500 PERIMETER	Bio-Rad	1987-02-20	39
K853290	TECHNA VISION AUTO-PERIMETER	Techna Vision	1985-11-12	99
K852936	THE FIELDMASTER MODEL 275	Synemed, Inc.	1985-10-15	97
K852639	HUMPHREY FIELD ANALYZER MODEL 630	Zeiss Humphrey System	1985-09-18	90
K850191	DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU	Bio-Rad	1985-03-04	45
K844570	QUANTUM 412	Keta Corp.	1984-12-05	12
K841099	OCTOPUS 500/500E	Cilco, Inc.	1984-06-19	99
K832555	OCUMAP 100 AUTOPERIMETER	Shorashim	1984-02-10	193
K832175	DIGILAB 350 THE KRAKAU PERIMETER	Bio-Rad	1983-08-16	41
K832142	DICON GLAUCOMA DIAG. CENTER 2000 SERIES	CooperVision, Inc.	1983-08-01	27
K822853	MODEL 200 SQUID	Synemed, Inc.	1982-10-18	21
K822601	FIXATION MONITOR	West Coast Optical Instruments, Inc.	1982-09-30	34
K822580	AUTO PERIOMETER 3000	Dicon, Inc.	1982-09-30	36
K821940	THE HUMPHREY FIELD ANALYZER MODEL 610	Zeiss Humphrey System	1982-07-28	29
K811347	DICON AUTO PERIMETER 2000	Dicon, Inc.	1981-08-20	100
K811346	DICON AUTO PERIMETER 200	Dicon, Inc.	1981-08-20	100
K803159	AUTOMATED PERIMETERS	Coburn Optical Ind., Inc.	1981-02-04	58
K800722	AUTO-FIELD D AUTOMATED VISUAL DETECTOR	Cavitron Corp.	1980-04-29	28
K791295	BAYLOR VISUAL FIELDS PROGRAMMER	Schiff Harding Waite	1979-08-10	31
K781462	AUTO-FIELD II OPHTHALMIC FIELD SCANNER	Cavitron Corp.	1978-09-14	20
K780414	OCTOPUS	Hitron Corp.	1978-04-10	26

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