510(k) Report

FDA applicant

Radiometer Medical Aps

Bronshoj, DK28 decisions2004–201755 recalls

FDA records 28 decisions for Radiometer Medical Aps (Bronshoj, DK) from 2004 to 2017: 28 510(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 46 predicates, 23 of them its own earlier devices. 55 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 Radiometer Medical Aps’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2010: 32011: 22012: 52013: 52014: 12015: 22016: 12017: 2
2007high 5 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007: 22008: 12009: 22010: 12011: 42012: 52013: 22014: 22015: 32016: 12017: 32018: 42019: 32020: 72021: 32022: 12024: 12025: 12026 (partial year): 1
2007high 7 (2020) · low 0 (2023)2026

Class I Class II/III not classified

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

Planning a device like Radiometer Medical Aps’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?

  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph13decisions
  • JJSControls For Blood-Gases, (Assayed And Unassayed)3decisions
  • MQMBilirubin (Total And Unbound) In The Neonate Test System2decisions
  • LKDMonitor, Carbon-Dioxide, Cutaneous2decisions
  • JHXFluorometric Method, Cpk Or Isoenzymes2decisions
  • CIGDiazo Colorimetry, Bilirubin1decision

Also: JKA (1), JJY (1), CEM (1), CGL (1), KHO (1).

Whose devices does it build on?

Its devices cite 46 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 36 times; 23 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.

  • K092686ABL90 Flex SeriesRadiometer Medical Aps · 20106cite it
  • K041874ABL800 FlexRadiometer Medical Aps · 20046cite it
  • K050869Modification to ABL800 FlexRadiometer Medical Aps · 20054cite it
  • K043218ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps · 20053cite it
  • K120197ABL90 FlexRadiometer Medical Aps · 20122cite it
  • K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 20102cite it

What has FDA decided for it lately?

  • K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017
  • K170882ABL90 Flex, ABL90 Flex PlusRadiometer Medical Aps · 2017
  • K160153ABL90 Flex PlusRadiometer Medical Aps · 20165 recalls
  • K142898ABL800 FLEX with AQURE connectivityRadiometer Medical Aps · 20153 recalls
  • K150226Hematocrit and Metabolite QUALICHECKRadiometer Medical Aps · 2015
  • K132691ABL90 FlexRadiometer Medical Aps · 2014
  • K131988ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
  • K130144ABL90 FlexRadiometer Medical Aps · 20133 recalls

All 28 as Radiometer Medical Aps →

What has been recalled?

55 recalls linked to its devices; the latest:

  • K041874The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained…Aug 18, 2026Class II
  • K092686Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90…Mar 21, 2025Class II
  • K041874ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended…May 31, 2024Class II
  • K041874ABL800 Flex Analyzer Model Numbers 393-800 and 393-801May 18, 2022Class II
  • K092686E3800 PC Units (spare parts)Apr 14, 2021Class II
  • K160153Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as…Apr 14, 2021Class II

Other applicant names beginning “Radiometer”

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

Radiometer America, Inc. 50Radiometer Medicals Aps 5Radiometer Medical A/S 2Radiometer Basel AG 1