Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
RaySearch Laboratories AB (PUBL) · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
240 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | 2025-12-22 | 168 | 0 |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025-04-17 | 203 | 2 |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2 | RaySearch Laboratories AB (PUBL) | 2025-04-04 | 420 | 2 |
| K222312 | RayStation 12A | RaySearch Laboratories AB (PUBL) | 2023-03-29 | 240 | 6 |
| K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | 2022-04-15 | 87 | 5 |
| K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021-09-08 | 84 | 5 |
| K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021-06-29 | 118 | 5 |
| K200569 | RayStation | RaySearch Laboratories AB (PUBL) | 2020-09-24 | 204 | 6 |
| K200487 | RayCare 3.1 | RaySearch Laboratories AB (PUBL) | 2020-06-10 | 104 | 2 |
| K191384 | RayCare 2.3 | RaySearch Laboratories AB (PUBL) | 2019-07-08 | 46 | 0 |
| K190387 | RayStation | RaySearch Laboratories AB (PUBL) | 2019-06-19 | 120 | 7 |
| K180379 | RayStation 7 | RaySearch Laboratories AB (PUBL) | 2018-04-25 | 72 | 3 |
| K171536 | RayStation | RaySearch Laboratories AB (PUBL) | 2017-06-27 | 33 | 2 |
| K170355 | RayStation 6 | RaySearch Laboratories AB (PUBL) | 2017-03-02 | 24 | 1 |
| K160093 | RayStation | RaySearch Laboratories AB (PUBL) | 2016-04-08 | 80 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda