Radiometer Medicals Aps: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Radiometer Medicals Aps” (first 2024, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 267 days. Since 2017 the median was 267 days, against 234 days for all cleared 510(k)s in the same product codes. 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
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 246 |
| 2025 | 1 | 273 |
| 2026 | 3 | 267 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Radiometer Medicals Aps took a median 267 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 234 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 2 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
Review panels
Most recent Radiometer Medicals Aps 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252488 | ABL90 FLEX PLUS System | CGA | 2026-05-01 | 266 |
| K252475 | ABL90 FLEX PLUS System | JGS | 2026-05-01 | 267 |
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | CHL | 2026-04-10 | 270 |
| K241037 | ABL90 FLEX PLUS System | CEM | 2025-01-14 | 273 |
| K240998 | ABL90 FLEX PLUS System | CHL | 2024-12-13 | 246 |
Recalls
openFDA lists no recalls under a recalling firm named Radiometer Medicals Aps.
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.
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 Medical Aps (28 510(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 Medicals Aps?
FDA lists 5 510(k) clearances under the applicant name “Radiometer Medicals Aps” (first 2024, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Radiometer Medicals Aps?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiometer Medicals Aps is 267 days. Since 2017: 267 days, versus 234 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Radiometer Medicals Aps?
The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 2); CEM (Electrode, Ion Specific, Potassium, 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 5 Radiometer Medicals Aps clearances with predicates and recalls
- Run predicate analysis for product code CHL, Radiometer Medicals 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.