Radiometer Medical Aps: FDA filings under this applicant name

FDA lists 28 510(k) clearances under the applicant name “Radiometer Medical Aps” (first 2004, latest 2017), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 124 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Radiometer Medical Aps took a median 160 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 198 days.

Top product codes

Plus 1 more product codes.

Review panels

• Clinical Chemistry (26)
• Anesthesiology (2)

Most recent Radiometer Medical Aps 510(k) clearances

18 earlier clearances. See the full list in Caduvo.

Recalls

25 product recalls in 17 recall events; 5 initiated in the last five years. Most recent: 2025-03-21.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Radiometer Medical Aps is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT06834880: AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study (Completed, started 2025-01-27)
• NCT06823648: Clinical Precision and In-use Analyte Stability Study for 19 Parameters in Adult Arterial Whole Blood for PICO70 and SafePICO (Completed, started 2024-06-18)
• NCT06702267: Clinical Precision and In-use Analyte Stability Study for Four (4) Parameters in Neonate Arterial Blood for PICO70 and SafePICO (Completed, started 2023-12-12)
• NCT07051278: ABL90 FLEX PLUS Method Comparison Neonatal Capillary (Completed, started 2023-11-10)
• NCT06078956: ABL90 Flex Plus Method Comparison Study_Adults (Completed, started 2023-07-08)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Radiometer America, Inc. (50 510(k)s)
• Radiometer Medicals Aps (5 510(k)s)
• Radiometer Medical A/S (2 510(k)s)
• Radiometer Basel AG (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Radiometer Medical Aps?

FDA lists 28 510(k) clearances under the applicant name “Radiometer Medical Aps” (first 2004, latest 2017), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Radiometer Medical Aps?

The median time from FDA receipt to decision across 510(k)s cleared under the name Radiometer Medical Aps is 124 days.

Which FDA product codes appear under Radiometer Medical Aps?

The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 13); JJS (Controls For Blood-Gases, (Assayed And Unassayed), 3); JHX (Fluorometric Method, Cpk Or Isoenzymes, 2).

Next steps

• See all 28 Radiometer Medical Aps clearances with predicates and recalls
• Run predicate analysis for product code CHL, Radiometer Medical Aps's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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