510(k) Report

FDA applicant

Medica Corp.

Bedford, MA56 decisions1979–20243 recalls

FDA records 56 decisions for Medica Corp. (Bedford, MA) from 1979 to 2024: 56 510(k) clearances. Most are in product codes JGS (Electrode, Ion Specific, Sodium) and CEM (Electrode, Ion Specific, Potassium). Its devices cite 3 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Medica Corporation”, “Medica S.R.L.”, “Medica, Inc.”.

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 Medica Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 22008: 42009: 62010: 32011: 92012: 12013: 22014: 12016: 12023: 22024: 1
2007high 9 (2011) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2025

2010: 12017: 12025: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medica Corp.’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?

  • JGSElectrode, Ion Specific, Sodium9decisions
  • CEMElectrode, Ion Specific, Potassium4decisions
  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph4decisions
  • JFPElectrode, Ion Specific, Calcium3decisions
  • CGAGlucose Oxidase, Glucose3decisions
  • CIGDiazo Colorimetry, Bilirubin3decisions

Also: CGZ (2), LBS (2), CIX (2), JGJ (1), DBL (1), DCF (1).

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 2 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.

  • K000926Easyelectrolyte Analyzer and Rapidlyte AnalyzerMedica Corp. · 20004cite it
  • K902237Medica Iif Anti-Skin Antibody Test KitMedica Corp. · 19901cites it
  • K070057Easyra Clinical Chemistry AnalyzerMedica Corp. · 20071cites it
  • K963763Easylyte Sodium/Potassium/Chloride/Lithium AnalyzerMedica Corp. · 19961cites it
  • K021515Easystat PH, PCO2, PO2, HCT, NA+, K+, CA++ AnalyzerMedica Corp. · 20021cites it
  • K963694Easylyte Calcium/Chloride AnalyzerMedica Corp. · 19961cites it

What has FDA decided for it lately?

  • K220328EasyStat 300Medica Corporation · 2024
  • K220396EasyStat 300Medica Corporation · 2023
  • K211559EasyStat 300Medica Corporation · 2023
  • K152327EasyLyte Na/K/Cl/Ca AnalyzerMedica Corporation · 2016
  • K130080Easyra CK-MB Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP Quality Control MaterialMedica Corporation · 2014
  • K123586Easyra Creatinine ReagentMedica Corporation · 2013
  • K123802Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentMedica Corp. · 2013
  • K120497Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc MaterialMedica Corp. · 20121 recall

All 47 as Medica Corp. →All 7 as Medica Corporation →The one decision as Medica S.R.L. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K021515Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.Dec 31, 2025Class II
  • K120497EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of…Apr 11, 2017Class II
  • K070057EasyRA Cuvette Segment 1, P/N 007000-001 (In Vitro Diagnostic ) EasyRA Cuvette Segments…Mar 29, 2010

Other applicant names beginning “Medica”

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

Medica Holdings, LLC 3Medica-Rents Co., Ltd. 1Medica Health, Ltd. 1Medica USA, Inc. 1