510(k) Report

FDA applicant

Hemametrics

Kaysville, UT1 decision2002–20020 recalls

FDA records 1 decision for Hemametrics (Kaysville, UT) in 2002: 1 510(k) clearance. All are in product code FIL (System, Dialysate Delivery, Single Pass). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Hemametrics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hemametrics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FILSystem, Dialysate Delivery, Single Pass1decision

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.

  • K011741Crit-Line Monitor Iii Tqa (CLM Tqa)Hemametrics · 20021cites it

What has FDA decided for it lately?

  • K011741Crit-Line Monitor Iii Tqa (CLM Tqa)Hemametrics · 2002

The one decision as Hemametrics →