510(k) Report

FDA applicant

Immunexpress, Inc.

Seattle, WA3 decisions2017–20230 recalls

FDA records 3 decisions for Immunexpress, Inc. (Seattle, WA) from 2017 to 2023: 3 510(k) clearances. All are in product code PRE (Rt-Qpcr Assay For Mrna Transcript Immune…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

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

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

FDA decisions per year

1in 2023

2017: 12021: 12023: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Immunexpress, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • PRERt-Qpcr Assay For Mrna Transcript Immune Biomarkers3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203748SeptiCyte RAPIDImmunexpress, Inc. · 20211cites it
  • K163260SeptiCyte LABImmunexpress, Inc. · 20171cites it

What has FDA decided for it lately?

  • K232095SeptiCyte RAPIDImmunexpress, Inc. · 2023
  • K203748SeptiCyte RAPIDImmunexpress, Inc. · 2021
  • K163260SeptiCyte LABImmunexpress, Inc. · 2017

All 3 as Immunexpress, Inc. →