Lunit, Inc.: FDA clearances and approvals
Lunit, Inc. has 6 FDA 510(k) clearances (first 2021, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 138 days. Since 2017 its median was 138 days, against 153 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 164 |
| 2022 | 0 | — |
| 2023 | 1 | 168 |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 2 | 100 |
Review time against the same product codes
Since 2017, Lunit, Inc.'s cleared 510(k)s took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 153 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 5 | 5 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 1 | 1 |
Review panels
- Radiology (6)
Most recent Lunit, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260320 | Lunit INSIGHT MMG (v1.1.10) | QDQ | 2026-04-23 | 83 |
| K253796 | Lunit INSIGHT DBT (V1.2) | QDQ | 2026-03-26 | 118 |
| K242652 | Lunit INSIGHT DBT v1.1 | QDQ | 2024-10-04 | 30 |
| K231470 | Lunit INSIGHT DBT | QDQ | 2023-11-06 | 168 |
| K211678 | Lunit INSIGHT MMG | QDQ | 2021-11-17 | 169 |
| K211733 | Lunit INSIGHT CXR Triage | QFM | 2021-11-10 | 159 |
Recalls
openFDA lists no recalls under a recalling firm named Lunit, Inc..
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.
Device clinical trials
Lunit, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05619029: Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on X-ray (Completed, started 2021-06-02)
- NCT05615298: Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer (Completed, started 2020-06-15)
- NCT05614232: Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on Chest X-ray (Completed, started 2020-02-11)
Frequently asked questions
How many FDA 510(k) clearances does Lunit, Inc. have?
Lunit, Inc. has 6 FDA 510(k) clearances (first 2021, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Lunit, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lunit, Inc.'s cleared 510(k)s is 138 days. Since 2017: 138 days, versus 153 days for all cleared 510(k)s in the same product codes.
What devices does Lunit, Inc. make?
Its most frequent FDA product codes are QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, 5); QFM (Radiological Computer-Assisted Prioritization Software For Lesions, 1).
Has Lunit, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lunit, Inc. Related entities may recall under other names.
Next steps
- See all 6 Lunit, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QDQ, Lunit, Inc.'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.