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

HKO — Predicate Candidate Screening

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

75 daysmedian FDA review time

194 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days
K031831	TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM	Topcon Medical Systems, Inc.	2003-12-19	189
K000327	WAVESCAN WAVEFRONT SYSTEM MODEL HS 1	Visx, Incorporated	2000-05-02	90
K951179	DIGITAL RETINOSCOPIC PHOTOMETER	Kudi Kalu, Inc.	1995-05-30	75
K945959	VIDEO VISION ANALYZER (VIVA), VRB 100	Tomey Corporation USA	1995-03-01	84
K942242	AUTO REF-KERATOMETER, RK-3	Cannon U.S.A., Inc.	1994-09-02	116
K940516	AUTO REFF-30	Canon, Inc.	1994-07-12	158
K925304	AUTOREF LENSMETER RL-10	Canon USA, Inc.	1994-02-17	484
K924741	OPTEC 3000	Stereo Optical Co., Inc.	1993-04-06	196
K924778	BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8	R.H. Burton Co.	1993-04-05	194
K924790	BURTON AUTO REFRACTOR - MODEL BAR-7	R.H. Burton Co.	1993-04-05	194
K904828	OPTEC 2300 AFVT, ARMED FORCES VISION TESTER	Stereo Optical Co., Inc.	1991-01-18	86
K902500	AR-1600G AUTO-REFRACTOMETER	Nidek, Inc.	1990-07-27	52
K901583	SHIN NIPPON AUTO REFRACTOMETER QR-007N	Soderberg, Inc.	1990-06-22	79
K901513	NIDEK RT-1200S (MARCO TRS-1200)	Nidek, Inc.	1990-06-08	70
K890559	NIDEK AR-1200	Nidek, Inc.	1989-02-27	21
K883200	CANON AUTOREFRACTOMETER R-22	Canon USA, Inc.	1988-08-18	21
K882287	CANON AUTOREFRACTOMETER R-20	Canon USA, Inc.	1988-07-01	30
K882191	NIDEK ARK-2000	Nidek, Inc.	1988-07-01	38
K871611	ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540	Allergan Humphrey	1987-05-18	38
K862521	BAUSCH & LOMB GR-3 REFRACTOR	Bausch & Lomb, Inc.	1986-07-11	10
K861065	AR-1100 AUTOMATIC REFRACTOR	Nidek, Inc.	1986-04-09	20
K861062	AR-1600 AUTOMATIC REFRACTOR	Nidek, Inc.	1986-04-04	15
K861066	AR-1000 AUTOMATIC REFRACTOR	Nidek, Inc.	1986-04-04	15
K841861	CANON AUTOREF R-10	Canon USA, Inc.	1984-10-05	154
K843042	VISION TESTER	Stereo Optical Co., Inc.	1984-10-05	64
K831083	AUTO REFRACTOMETER	Nidek, Inc.	1983-06-10	67
K820877	AUTOMATIC OBJECTIVE REFRACTOR 2000	Dicon, Inc.	1982-06-25	87
K812896	I.V.E. REFRACTION SYSTEM	Bausch & Lomb, Inc.	1981-12-02	48
K812063	SR-1V DATA PRINTER	American Optical Corp.	1981-08-18	28
K802183	SR-IV PROGRAMMED SUBJECTIVE REFRACTOR	American Optical Corp.	1981-04-23	226
K802958	AUTO REFRACTOMETER NR-1000	Nippon Kogaku, Inc.	1981-04-23	154
K802029	OBJECTIVE REFRACTOR	Zeiss Humphrey System	1980-11-12	83
K801906	DIOPTRON III AUTOREFRACTOR	Coherent Medical Division	1980-08-27	16
K781014	AUTOREFRACTOR, SUBJECTIVE	Cavitron Corp.	1978-09-07	83
K771914	SUBJECTIVE REFRACTOR, MOSEL SR-111	American Optical Corp.	1977-11-09	28

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