Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QJF · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
196 daysmedian FDA review time
270 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251678 | Swift Ray 1 | Swift Medical, Inc. | 2026-02-24 | 270 | 0 |
| K242669 | SnapshotGLO (KB100) | Kent Imaging, Inc. | 2025-03-26 | 202 | 1 |
| K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectra | Precision Healing, LLC | 2023-12-05 | 264 | 0 |
| 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 |
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