Atlas FDA

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

Lxn Corp. — Predicate Candidate Screening

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

133 daysmedian FDA review time
346 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002688PERSONAL GLUCOSE CONTROL CHARTING SYSTEMLxn Corp.2001-02-011560
K991754GO GLUCOSE MONITORING SYSTEMLxn Corp.1999-09-081070
K990942DUET II GLUCOSE CONTROL MONITORING SYSTEMLxn Corp.1999-08-021330
K973140DUET GLUCOSE CONTROL MONITORING SYSTEMLxn Corp.1997-10-31710
K962597LXN FRUCTOSAMINE TEST SYSTEMLxn Corp.1997-06-133460
K960034LXN BLOOD GLUCOSE TEST SYSTEMLxn Corp.1996-06-281770
K955629LXN FRUCTOSAMINE TESTLxn Corp.1996-03-201000

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