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

Illumina, Inc. — Predicate Candidate Screening

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

208 daysmedian FDA review time

328 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
DEN130042	MISEQDX UNIVERSAL KIT 1.0	Illumina, Inc.	2013-11-19	46	0
K124006	ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY	Illumina, Inc.	2013-11-19	328	0
DEN130011	ILLUMINA MISEQDX PLATFORM	Illumina, Inc.	2013-11-19	57	0
K132750	ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY	Illumina, Inc.	2013-11-19	77	2
K093128	ILLUMINA BEADXPRESS SYSTEM	Illumina, Inc.	2010-04-28	208	0
K093129	ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II	Illumina, Inc.	2010-04-28	208	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