Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Olea Medical — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
195 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223091 | CT Perfusion V1.0 | Olea Medical | 2023-06-09 | 252 | 0 |
| K223532 | Olea S.I.A. Neurovascular V1.0 | Olea Medical | 2023-06-06 | 195 | 0 |
| K230552 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | 2023-04-26 | 57 | 0 |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | 2023-01-13 | 53 | 0 |
| K211431 | breastscape v1.0 | Olea Medical | 2021-08-02 | 87 | 0 |
| K152602 | Olea Sphere V3.0 | Olea Medical | 2016-03-03 | 174 | 0 |
| K132095 | OLEA SPHERE | Olea Medical | 2013-12-26 | 171 | 0 |
| K120196 | OLEA SPHERE | Olea Medical | 2012-04-19 | 87 | 0 |
| K111161 | PERFSCAPE V2.0 | Olea Medical | 2011-11-04 | 193 | 0 |
| K091444 | PERFSCAPE | Olea Medical | 2009-07-20 | 66 | 0 |
| K083491 | NEUROSCAPE | Olea Medical | 2009-02-19 | 86 | 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