Illumina, Inc.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Illumina, Inc.” (first 2010, latest 2013), plus 2 PMA and 2 De Novo decisions, across 7 product codes in 3 review panels. Median 510(k) review time under this name: 208 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 202 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | 2 | 0 |
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 1 | 1 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 1 | 1 |
| PFF | High Throughput Dna Sequence Analyzer | 1 | 0 |
| PFR | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection | 1 | 1 |
| PFS | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection | 1 | 1 |
| PFT | Reagents For Molecular Diagnostic Test Systems | 1 | 0 |
Review panels
- Pathology (5)
- Clinical Toxicology (2)
- Clinical Chemistry (1)
Most recent Illumina, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132750 | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY | PFS | 2013-11-19 | 77 |
| K124006 | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY | PFR | 2013-11-19 | 328 |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | NPQ | 2010-04-28 | 208 |
| K093128 | ILLUMINA BEADXPRESS SYSTEM | NSU | 2010-04-28 | 208 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230011 | PMA | TruSight Oncology Comprehensive | 2024-08-21 |
| P160038 | PMA | Praxis Extended RAS Panel | 2017-06-29 |
| DEN130042 | De Novo | Reagents For Molecular Diagnostic Test Systems | 2013-11-19 |
| DEN130011 | De Novo | High Throughput Dna Sequence Analyzer | 2013-11-19 |
Recalls
9 product recalls in 7 recall events; 6 initiated in the last five years. Most recent: 2025-10-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
ILLUMINA, INC. (ILMN): EDGAR filings, CIK 1110803. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Illumina, Inc.?
FDA lists 4 510(k) clearances under the applicant name “Illumina, Inc.” (first 2010, latest 2013), plus 2 PMA and 2 De Novo decisions, across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Illumina, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Illumina, Inc. is 208 days.
Which FDA product codes appear under Illumina, Inc.?
The most frequent FDA product codes under this applicant name are PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System, 2); NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr, 1); NSU (Instrumentation For Clinical Multiplex Test Systems, 1).
Next steps
- See all 4 Illumina, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PQP, Illumina, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.