510(k) Report

FDA applicant

Cue Health, Inc.

San Diego, CA2 decisions2023–20230 recalls

FDA records 2 decisions for Cue Health, Inc. (San Diego, CA) in 2023: 1 510(k) clearance and 1 De Novo grant. All are in product code QWB (Over-The-Counter Molecular Test To Detect…). Its devices cite 1 predicate, 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 Cue Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Cue Health, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cue Health, 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?

  • QWBOver-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens2decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • DEN220028Cue COVID-19 Molecular TestCue Health, Inc. · 20233cite it

What has FDA decided for it lately?

  • K232643Cue COVID-19 Molecular TestCue Health, Inc. · 2023
  • DEN220028Cue COVID-19 Molecular TestCue Health, Inc. · 2023

All 2 as Cue Health, Inc. →