Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kent Imaging, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242669 | SnapshotGLO (KB100) | Kent Imaging, Inc. | 2025-03-26 | 202 | 1 |
| K240601 | SnapshotNIR model KD205 | Kent Imaging, Inc. | 2024-04-02 | 29 | 0 |
| K163070 | Kent Camera | Kent Imaging, Inc. | 2017-05-05 | 184 | 0 |
| K113507 | KENT CAMERA | Kent Imaging, Inc. | 2012-08-08 | 254 | 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