Olea Medical: FDA clearances and approvals
Olea Medical has 11 FDA 510(k) clearances (first 2009, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time: 87 days. Since 2017 its median was 87 days, against 124 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Olea Medical.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 87 |
| 2013 | 1 | 171 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 174 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 87 |
| 2022 | 0 | — |
| 2023 | 4 | 126 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Olea Medical's cleared 510(k)s took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 9 | 9 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (11)
Most recent Olea Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223091 | CT Perfusion V1.0 | LLZ | 2023-06-09 | 252 |
| K223532 | Olea S.I.A. Neurovascular V1.0 | LLZ | 2023-06-06 | 195 |
| K230552 | MR DWI/FLAIR Measurement V1.0 | LLZ | 2023-04-26 | 57 |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | LLZ | 2023-01-13 | 53 |
| K211431 | breastscape v1.0 | QIH | 2021-08-02 | 87 |
| K152602 | Olea Sphere V3.0 | LLZ | 2016-03-03 | 174 |
| K132095 | OLEA SPHERE | LLZ | 2013-12-26 | 171 |
| K120196 | OLEA SPHERE | LLZ | 2012-04-19 | 87 |
| K111161 | PERFSCAPE V2.0 | LLZ | 2011-11-04 | 193 |
| K091444 | PERFSCAPE | LNH | 2009-07-20 | 66 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-08-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Olea Medical's product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances does Olea Medical have?
Olea Medical has 11 FDA 510(k) clearances (first 2009, latest 2023), across 3 product codes in 1 review panel.
How long does FDA take to clear Olea Medical's 510(k)s?
The median time from FDA receipt to decision across Olea Medical's cleared 510(k)s is 87 days. Since 2017: 87 days, versus 124 days for all cleared 510(k)s in the same product codes.
What devices does Olea Medical make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 9); LNH (System, Nuclear Magnetic Resonance Imaging, 1); QIH (Automated Radiological Image Processing Software, 1).
Has Olea Medical had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Olea Medical; the most recent began 2023-08-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 11 Olea Medical clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Olea Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.