510(k) Report

FDA applicant

Illumina, Inc.

San Diego, CA6 decisions2010–20242 recalls

FDA records 6 decisions for Illumina, Inc. (San Diego, CA) from 2010 to 2024: 4 510(k) clearances and 2 original PMA approvals. Most are in product codes PQP (Next Generation Sequencing Oncology Panel…) and NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr). Its devices cite 4 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Illumina, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010: 22013: 22017: 12024: 1
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

2in 2014

2014: 2
2010high 2 (2014) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Illumina, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Illumina, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System2decisions
  • NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr1decision
  • NSUInstrumentation For Clinical Multiplex Test Systems1decision
  • PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants…1decision
  • PFSSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence…1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • P230011TruSight Oncology ComprehensiveIllumina, Inc. · 2024
  • P160038Praxis Extended RAS PanelIllumina, Inc. · 2017
  • K124006Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc. · 2013
  • K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc. · 20132 recalls
  • K093129Illumina Verncode Genotyping Test for Facor V and Factor IIIllumina, Inc. · 2010
  • K093128Illumina Beadxpress SystemIllumina, Inc. · 2010

All 6 as Illumina, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K132750Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0…Nov 13, 2014Class II
  • K132750Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system…Nov 6, 2014Class III