510(k) Report

FDA applicant

Epocal, Inc.

Ottawa, CA7 decisions2006–202024 recalls

FDA records 7 decisions for Epocal, Inc. (Ottawa, CA) from 2006 to 2020: 7 510(k) clearances. Most are in product codes CGL (Electrode, Ion Based, Enzymatic, Creatinine) and CEM (Electrode, Ion Specific, Potassium). Its devices cite 12 predicates, 5 of them its own earlier devices. 24 recalls are 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 Epocal, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2009: 12010: 22012: 12018: 12020: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008: 12010: 12011: 12013: 12020: 12022: 22023: 42024: 92025: 32026 (partial year): 1
2007high 9 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Epocal, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CGLElectrode, Ion Based, Enzymatic, Creatinine1decision
  • CEMElectrode, Ion Specific, Potassium1decision
  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph1decision
  • CDSElectrode, Ion Specific, Urea Nitrogen1decision
  • KHPAcid, Lactic, Enzymatic Method1decision
  • CGAGlucose Oxidase, Glucose1decision

Also: JGS (1).

Whose devices does it build on?

Its devices cite 12 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K093297Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeEpocal, Inc. · 20102cite it
  • K061597Epoc Blood Analysis SystemEpocal, Inc. · 20062cite it
  • K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc. · 20121cites it
  • K092849Blood Collection Tube Samples for Use with Point of Care Blood AnalyzerEpocal, Inc. · 20101cites it
  • K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc. · 20181cites it

What has FDA decided for it lately?

  • K200107epoc Blood Analysis SystemEpocal, Inc. · 202019 recalls
  • K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc. · 2018
  • K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc. · 2012
  • K093297Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeEpocal, Inc. · 20101 recall
  • K092849Blood Collection Tube Samples for Use with Point of Care Blood AnalyzerEpocal, Inc. · 2010
  • K090109Blood Gas, Electrolyte and Metabolite Test CardEpocal, Inc. · 20093 recalls
  • K061597Epoc Blood Analysis SystemEpocal, Inc. · 20062 recalls

All 7 as Epocal, Inc. →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K200107epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material…Apr 2, 2026Class II
  • K200107epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.Jul 7, 2025Class II
  • K200107epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material…Mar 19, 2025Class II
  • K200107epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material…Mar 19, 2025Class II
  • K200107epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number…Nov 22, 2024Class II
  • K200107epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number…Nov 22, 2024Class II