Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elekta , Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
264 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141855 | CLARITY | Elekta , Ltd. | 2014-10-08 | 91 | 0 |
| K123808 | AGILITY | Elekta , Ltd. | 2013-04-04 | 114 | 1 |
| K121663 | CLARITY | Elekta , Ltd. | 2012-12-05 | 183 | 0 |
| K121328 | AGILITY | Elekta , Ltd. | 2012-06-12 | 40 | 3 |
| K111332 | CLARITY OBP SYSTEM | Elekta , Ltd. | 2012-01-30 | 264 | 0 |
| K102200 | INTEGRITY MODEL 1014284 | Elekta , Ltd. | 2010-11-04 | 92 | 0 |
| K100115 | XVI R4.5 | Elekta , Ltd. | 2010-03-10 | 54 | 4 |
| K082122 | MLCI2 | Elekta , Ltd. | 2008-08-29 | 32 | 1 |
| K080585 | DESKTOP PRO | Elekta , Ltd. | 2008-06-11 | 100 | 1 |
| K042794 | BEAM MODULATOR, MODEL 4513 332 8000 | Elekta , Ltd. | 2005-01-31 | 116 | 0 |
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