Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MolecuLight, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
160 daysmedian FDA review time
196 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213840 | MolecuLight I:X | MolecuLight, Inc. | 2022-05-18 | 160 | 0 |
| K211901 | MolecuLightDX | MolecuLight, Inc. | 2021-07-21 | 30 | 0 |
| K210882 | MolecuLight I:X | MolecuLight, Inc. | 2021-06-22 | 89 | 0 |
| K191371 | MolecuLight i:X | MolecuLight, Inc. | 2019-12-04 | 196 | 0 |
| DEN180008 | MolecuLight i:X | MolecuLight, Inc. | 2018-07-31 | 165 | 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