Atlas FDA

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

Lenstec, Inc. — Predicate Candidate Screening

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

136 daysmedian FDA review time
395 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161776Lenstec LC Injection systemLenstec, Inc.2016-11-291530
K122848LENSTEC LC INJECTION SYSTEMLenstec, Inc.2013-10-183950
K091915FLUID ISOLATION DEVICELenstec, Inc.2009-10-271190
K063802LENSTEC LC INJECTION SYSTEMLenstec, Inc.2007-05-071360
K060533LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEMLenstec, Inc.2006-04-14450
K050638LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLELenstec, Inc.2005-05-31810

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