510(k) Report

FDA applicant

Radiometer America, Inc.

Westlake, OH50 decisions1983–201623 recalls

FDA records 50 decisions for Radiometer America, Inc. (Westlake, OH) from 1983 to 2016: 50 510(k) clearances. Most are in product codes CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…) and JJS (Controls For Blood-Gases, (Assayed And…). Its devices cite 17 predicates, 12 of them its own earlier devices. 23 recalls are linked to its devices, 9 Class I.

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

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

10in 2022

2011: 12012: 22013: 22017: 12022: 10, 9 Class I
2007high 10 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Radiometer America, Inc. 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?

  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph15decisions
  • JJSControls For Blood-Gases, (Assayed And Unassayed)9decisions
  • JWYManual Antimicrobial Susceptibility Test Systems5decisions
  • JJYMulti-Analyte Controls, All Kinds (Assayed)2decisions
  • DQAOximeter2decisions
  • JGSElectrode, Ion Specific, Sodium2decisions

Also: LIE (1), CGA (1), CEM (1), JKS (1), GLY (1), CBT (1).

Whose devices does it build on?

Its devices cite 17 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 36 times; 12 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.

  • K980135QUALICHECK5+ Models S7730, S7740, S7750, S7760Radiometer America, Inc. · 19986cite it
  • K980130ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 19984cite it
  • K853990OSM3 HemoximeterRadiometer America, Inc. · 19854cite it
  • K991417Abl 735 AnalyzerRadiometer America, Inc. · 19993cite it
  • K954612Abl System 625, 615, 605Radiometer America, Inc. · 19952cite it
  • K973367ABL555 Blood Gas, Electrolyte & Metabolite SystemRadiometer America, Inc. · 19972cite it

What has FDA decided for it lately?

  • K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea…Radiometer America, Inc. · 2016
  • K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 20004 recalls
  • K991417Abl 735 AnalyzerRadiometer America, Inc. · 19992 recalls
  • K982928NPT7 Series PH/Blood Gas and CO-Oximetry SystemRadiometer America, Inc. · 19992 recalls
  • K980130ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 19985 recalls
  • K980135QUALICHECK5+ Models S7730, S7740, S7750, S7760Radiometer America, Inc. · 19981 recall
  • K974818ABL555 Blood Gas, Electrolyte & Metabolite SystemRadiometer America, Inc. · 19981 recall
  • K973367ABL555 Blood Gas, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1997

All 50 as Radiometer America, Inc. →

What has been recalled?

23 recalls linked to its devices; the latest:

  • K880641Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD ASTOct 20, 2022Class I

Other applicant names beginning “Radiometer”

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

Radiometer Medical Aps 28Radiometer Medicals Aps 5Radiometer Medical A/S 2Radiometer Basel AG 1