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

Allergan Medical Optics · Predicate Candidate Screening

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

88 daysmedian FDA review time

440 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K951462	AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM	Allergan Medical Optics	1995-06-15	77	0
K941603	AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE	Allergan Medical Optics	1994-07-06	96	0
K930320	AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR	Allergan Medical Optics	1994-04-07	440	0
K925254	AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38	Allergan Medical Optics	1993-01-07	80	0
K924235	AMO ELITE	Allergan Medical Optics	1992-12-23	121	1
K911998	MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM	Allergan Medical Optics	1991-07-26	88	0
K893199	PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR	Allergan Medical Optics	1989-06-16	51	0

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