510(k) Report

FDA applicant

Metrix Co.

Dubuque, IA6 decisions1977–201417 recalls

FDA records 6 decisions for Metrix Co. (Dubuque, IA) from 1977 to 2014: 6 510(k) clearances. Most are in product codes KPE (Container, I.V.) and HGM (System, Monitoring, Perinatal). 17 recalls are linked to its devices.

FDA’s records also spell it “The Metrix Company”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

16in 2024

2016: 12024: 16
2007high 16 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Metrix Co.’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?

  • KPEContainer, I.V.2decisions
  • HGMSystem, Monitoring, Perinatal1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • LHISet, I.V. Fluid Transfer1decision
  • FPDTube, Feeding1decision

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K030888Eva Empty Solution ContainerMetrix Co. · 20032cite it
  • K132424MetrixcareThe Metrix Company · 20141cites it

What has FDA decided for it lately?

  • K132424MetrixcareThe Metrix Company · 2014
  • K030888Eva Empty Solution ContainerMetrix Co. · 200317 recalls
  • K895922Metricare Empty Container SystemsMetrix Co. · 1990
  • K895924Metricare Drug ReservoirsMetrix Co. · 1990
  • K895923Metricare Enteral Feeding SystemMetrix Co. · 1990
  • K761201Echo-Cardiotrace, AutomaticMetrix Co. · 1977

All 5 as Metrix Co. →The one decision as The Metrix Company →

What has been recalled?

17 recalls linked to its devices; the latest:

  • K030888SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch…Oct 9, 2024Class II
  • K030888Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made…Oct 9, 2024Class II
  • K030888VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch…Oct 9, 2024Class II
  • K030888CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch…Oct 9, 2024Class II
  • K030888SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch…Oct 9, 2024Class II
  • K030888SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made…Oct 9, 2024Class II

Other applicant names beginning “Metrix”

FDA records each applicant name separately; these may or may not be the same firm.

Metrix Teknika, Inc. 4