Eurotrol B.V.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Eurotrol B.V.” (first 2006, latest 2019), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 36 |
| 2013 | 2 | 206 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 227 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 84 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eurotrol B.V. took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 78 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGM | Control, Hemoglobin | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| GLK | Control, Hematocrit | 1 | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (3)
Most recent Eurotrol B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | GGM | 2019-11-15 | 43 |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | GGM | 2019-02-01 | 126 |
| K152553 | CueSee Hypoxic | JJS | 2016-04-22 | 227 |
| K131595 | EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM | JJY | 2013-07-26 | 53 |
| K121467 | EUROTROL HEMATOCRIT CONTROL | GLK | 2013-05-10 | 358 |
| K121468 | EUROTROL GAS-ISE METABOLITES | JJY | 2012-06-22 | 36 |
| K060215 | ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 | JJX | 2006-03-24 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Eurotrol B.V..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Eurotrol B.V.?
FDA lists 7 510(k) clearances under the applicant name “Eurotrol B.V.” (first 2006, latest 2019), across 5 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 Eurotrol B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eurotrol B.V. is 56 days.
Which FDA product codes appear under Eurotrol B.V.?
The most frequent FDA product codes under this applicant name are GGM (Control, Hemoglobin, 2); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2); GLK (Control, Hematocrit, 1).
Next steps
- See all 7 Eurotrol B.V. clearances with predicates and recalls
- Run predicate analysis for product code GGM, Eurotrol B.V.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.