Atlas FDA

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

HNH — Predicate Candidate Screening

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

71 daysmedian FDA review time
134 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K912269LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RINGOcular Instruments, Inc.1991-08-07770
K912268LANDERS NOTCHED VITRECTOMY LENS RINGOcular Instruments, Inc.1991-08-07770
K912151LANDERS THREE STRUT VITRECTOMY LENS RINGOcular Instruments, Inc.1991-07-25710
K902496LANDERS VITRECTOMY LENS RING W/INFUSIONOcular Instruments, Inc.1990-07-24490
K863775RK VACUUM FIXATION RING SYSTEMAmeritek, Inc.1986-10-20240
K850991LANDERS VITRECTOMY LENS RING SYSTEMSOcular Instruments, Inc.1985-03-29180
K832912GELENDER VACUUM FIXATION RING SYSMiami Eye Technology, Inc.1984-01-101340

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