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

American Medical Optics — Predicate Candidate Screening

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

48 daysmedian FDA review time

101 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K860001	BARRAQUER-KRUMEICH REFRACTIVE SET	American Medical Optics	1986-02-04	33
K851264	AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS	American Medical Optics	1985-05-01	34
K851263	AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP	American Medical Optics	1985-05-01	34
K851262	AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA	American Medical Optics	1985-04-30	33
K844150	MEDICAL OPTICS PHACOEMULSIFICATION KIT	American Medical Optics	1984-12-11	48
K843966	ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS	American Medical Optics	1984-11-08	28
K843965	ARGON LASER PHOTOCOAGULATOR SYS	American Medical Optics	1984-11-06	26
K842197	AMERICAN MEDICAL OPTICS I/A KIT- IRRIG	American Medical Optics	1984-10-01	119
K842504	AMER. MEDICAL OPTICS DIGITAL KERATO-	American Medical Optics	1984-10-01	97
K842127	AMERICAN MEDICAL OPTICS IMAGING SYS	American Medical Optics	1984-09-07	101
K842251	AMERI. MEDICAL OPTICS ARGON LASER PHOTO	American Medical Optics	1984-08-15	77
K842250	AMER. MEDICAL OPTICS ARGON/KRYPTON LASE	American Medical Optics	1984-08-15	77
K842128	AMERICAN MEDICAL OPTICS PHOTOKERATO	American Medical Optics	1984-08-07	70
K841855	AMER. MED. OPTICS ARGON LASER PHOTO	American Medical Optics	1984-06-19	47
K841856	AMER. MED. OPTICS ARGON/KRYPTON LASER	American Medical Optics	1984-06-07	35
K833405	IRRIGATION ASPIRATION KIT	American Medical Optics	1984-01-06	98
K823222	INTRAOCULAR LENS GUIDE	American Medical Optics	1982-12-28	60

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