Arplay Medical S.A.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Arplay Medical S.A.” (first 2001, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 8 | 8 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
Review panels
- Radiology (9)
Most recent Arplay Medical S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010065 | CRANIAL STEREOTACTIC EQUIPMENT | IYE | 2002-07-02 | 540 |
| K004023 | INTRA OPERATIVE RADIATION THERAPY | IYE | 2001-09-21 | 268 |
| K003779 | IMMOBILIZATION SYSTEM FOR ENT | IYE | 2001-07-12 | 217 |
| K003778 | BREAST-BOARD (MULTIPLE) | IYE | 2001-06-08 | 183 |
| K010174 | TRAY ADAPTERS, MULTIPLE | IYE | 2001-04-18 | 90 |
| K010172 | LEAD BLOCKS | IXI | 2001-04-18 | 90 |
| K010063 | COUCH FOR TOTAL BODY RADIATION | IYE | 2001-04-02 | 84 |
| K010062 | STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM | IYE | 2001-03-13 | 64 |
| K004015 | BEAM BLOCK TRAYS | IYE | 2001-03-13 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Arplay Medical S.A..
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 Arplay Medical S.A.?
FDA lists 9 510(k) clearances under the applicant name “Arplay Medical S.A.” (first 2001, latest 2002), across 2 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 Arplay Medical S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arplay Medical S.A. is 90 days.
Which FDA product codes appear under Arplay Medical S.A.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 8); IXI (Block, Beam-Shaping, Radiation Therapy, 1).
Next steps
- See all 9 Arplay Medical S.A. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Arplay Medical S.A.'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.