510(k) Report

FDA applicant

Miris AB

Uppsala, SE2 decisions2018–20230 recalls

FDA records 2 decisions for Miris AB (Uppsala, SE) from 2018 to 2023: 1 510(k) clearance and 1 De Novo grant. All are in product code QEI (Breast Milk Macronutrients Test System). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2023

2018: 12023: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Miris AB by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QEIBreast Milk Macronutrients Test System2decisions

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.

  • DEN180007Miris Human Milk AnalyzerMiris AB · 20182cite it

What has FDA decided for it lately?

  • K223085Miris Human Milk Analyzer (HMA)Miris AB · 2023
  • DEN180007Miris Human Milk AnalyzerMiris AB · 2018

All 2 as Miris AB →