510(k) Report

FDA applicant

Hemocue, Inc.

Potomac, MD15 decisions1991–202010 recalls

FDA records 15 decisions for Hemocue, Inc. (Potomac, MD) from 1991 to 2020: 15 510(k) clearances. Most are in product codes GKR (System, Hemoglobin, Automated) and LFR (Glucose Dehydrogenase, Glucose). Its devices cite 5 predicates, 4 of them its own earlier devices. 10 recalls are linked to its devices.

FDA’s records also spell it “Hemocue AB”.

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 Hemocue, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12019: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2025

2010: 22011: 12012: 12013: 32014: 12025: 2
2007high 3 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Hemocue, 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?

  • GKRSystem, Hemoglobin, Automated6decisions
  • LFRGlucose Dehydrogenase, Glucose4decisions
  • CGAGlucose Oxidase, Glucose3decisions
  • GKLCounter, Cell, Automated (Particle Counter)1decision
  • KQOAutomated Urinalysis System1decision

Whose devices does it build on?

Its devices cite 5 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 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.

  • K032203Hemocue Hemoglobin 201 + System Article 121704Hemocue, Inc. · 20033cite it
  • K061047Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801Hemocue AB · 20063cite it
  • K041234Hemocue Hemoglobin 201DM Analyzing SystemHemocue, Inc. · 20041cites it
  • K181751HemoCue Hb 801 SystemHemocue AB · 20191cites it
  • K020935Hemocue Glucose 201 System, Article Number 120706Hemocue, Inc. · 20021cites it

What has FDA decided for it lately?

  • K201217HemoCue Hb 301 SystemHemocue AB · 2020
  • K181751HemoCue Hb 801 SystemHemocue AB · 2019
  • K071652Hemocue WBC SystemHemocue AB · 2007
  • K060765Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL 110712Hemocue AB · 2006
  • K061047Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801Hemocue AB · 2006
  • K053253Hemocue Albumin 201 Analyzing SystemHemocue AB · 20062 recalls
  • K041234Hemocue Hemoglobin 201DM Analyzing SystemHemocue, Inc. · 20041 recall
  • K041230Clinical Laboratory Analyzing SystemHemocue, Inc. · 20041 recall

All 9 as Hemocue, Inc. →All 6 as Hemocue AB →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K020935The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201…May 12, 2025Class II
  • K911141Hemocue Inc F/Glucose 201 Analyzer (25/VL 4VL/BX) Microcuvette.Apr 24, 2025Class II
  • K020935HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed…Oct 20, 2014Class II
  • K032203HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB…Jul 25, 2013Class II
  • K053253HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The…Jul 16, 2013Class II
  • K020935HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue…Jul 15, 2013Class II