Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lunit, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
159 daysmedian FDA review time
169 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260320 | Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | 2026-04-23 | 83 | 0 |
| K253796 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | 2026-03-26 | 118 | 0 |
| K242652 | Lunit INSIGHT DBT v1.1 | Lunit, Inc. | 2024-10-04 | 30 | 0 |
| K231470 | Lunit INSIGHT DBT | Lunit, Inc. | 2023-11-06 | 168 | 0 |
| K211678 | Lunit INSIGHT MMG | Lunit, Inc. | 2021-11-17 | 169 | 0 |
| K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021-11-10 | 159 | 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