Iline Microsystems, S.L.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Iline Microsystems, S.L.” (first 2019, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 104 days, against 231 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 305 |
| 2020 | 1 | 231 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 29 |
| 2024 | 0 | — |
| 2025 | 2 | 82 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Iline Microsystems, S.L. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 231 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | 5 | 5 |
Review panels
- Hematology (5)
Most recent Iline Microsystems, S.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251564 | microINR System | GJS | 2025-07-21 | 60 |
| K243543 | microINR System | GJS | 2025-02-27 | 104 |
| K231711 | microINR System | GJS | 2023-07-11 | 29 |
| K201185 | microINR System | GJS | 2020-12-18 | 231 |
| K180780 | microINR System | GJS | 2019-01-25 | 305 |
Recalls
openFDA lists no recalls under a recalling firm named Iline Microsystems, S.L..
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 Iline Microsystems, S.L.?
FDA lists 5 510(k) clearances under the applicant name “Iline Microsystems, S.L.” (first 2019, latest 2025), across 1 product code 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 Iline Microsystems, S.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Iline Microsystems, S.L. is 104 days. Since 2017: 104 days, versus 231 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Iline Microsystems, S.L.?
The most frequent FDA product codes under this applicant name are GJS (Test, Time, Prothrombin, 5).
Next steps
- See all 5 Iline Microsystems, S.L. clearances with predicates and recalls
- Run predicate analysis for product code GJS, Iline Microsystems, S.L.'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.