RaySearch Laboratories AB (PUBL): FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “RaySearch Laboratories AB (PUBL)” (first 2016, 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 111 days, against 121 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 |
|---|---|---|
| 2016 | 1 | 80 |
| 2017 | 2 | 28 |
| 2018 | 1 | 72 |
| 2019 | 2 | 83 |
| 2020 | 2 | 154 |
| 2021 | 2 | 101 |
| 2022 | 1 | 87 |
| 2023 | 1 | 240 |
| 2024 | 0 | — |
| 2025 | 3 | 203 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name RaySearch Laboratories AB (PUBL) took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 15 | 15 |
Review panels
- Radiology (15)
Most recent RaySearch Laboratories AB (PUBL) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252109 | RayStation (2024A SP3) | MUJ | 2025-12-22 | 168 |
| K242992 | RayCare (2024A SP1) | MUJ | 2025-04-17 | 203 |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | MUJ | 2025-04-04 | 420 |
| K222312 | RayStation 12A | MUJ | 2023-03-29 | 240 |
| K220141 | RayStation 11B | MUJ | 2022-04-15 | 87 |
| K211867 | RayStation 11.0 | MUJ | 2021-09-08 | 84 |
| K210645 | RayStation 10.1 | MUJ | 2021-06-29 | 118 |
| K200569 | RayStation | MUJ | 2020-09-24 | 204 |
| K200487 | RayCare 3.1 | MUJ | 2020-06-10 | 104 |
| K191384 | RayCare 2.3 | MUJ | 2019-07-08 | 46 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named RaySearch Laboratories AB (PUBL).
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.
- Raysearch Laboratories AB (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under RaySearch Laboratories AB (PUBL)?
FDA lists 15 510(k) clearances under the applicant name “RaySearch Laboratories AB (PUBL)” (first 2016, 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 RaySearch Laboratories AB (PUBL)?
The median time from FDA receipt to decision across 510(k)s cleared under the name RaySearch Laboratories AB (PUBL) is 104 days. Since 2017: 111 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under RaySearch Laboratories AB (PUBL)?
The most frequent FDA product codes under this applicant name are MUJ (System, Planning, Radiation Therapy Treatment, 15).
Next steps
- See all 15 RaySearch Laboratories AB (PUBL) clearances with predicates and recalls
- Run predicate analysis for product code MUJ, RaySearch Laboratories AB (PUBL)'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.