510(k) Report

FDA applicant

Hema Metrics, LLC

Ogden, UT1 decision2010–20100 recalls

FDA records 1 decision for Hema Metrics, LLC (Ogden, UT) in 2010: 1 510(k) clearance. All are in product code MSQ (Test, Urea (Breath Or Blood)). Its devices cite 1 predicate, 0 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 Hema Metrics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

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

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Which product codes does it file in?

  • MSQTest, Urea (Breath Or Blood)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K093834Crit-Line Anemia Management SoftwareHema Metrics, LLC · 20101cites it

What has FDA decided for it lately?

  • K093834Crit-Line Anemia Management SoftwareHema Metrics, LLC · 2010

The one decision as Hema Metrics, LLC →