Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cleerly, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
159 daysmedian FDA review time
216 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261210 | Cleerly Plaque | Cleerly, Inc. | 2026-07-29 | 106 | 0 |
| K260588 | Cleerly LABS | Cleerly, Inc. | 2026-07-29 | 159 | 0 |
| K242338 | Cleerly LABS (v2.0) | Cleerly, Inc. | 2025-03-07 | 212 | 0 |
| K231335 | Cleerly ISCHEMIA | Cleerly, Inc. | 2023-09-08 | 123 | 0 |
| K202280 | Cleerly Labs v2.0 | Cleerly, Inc. | 2020-10-02 | 52 | 0 |
| K190868 | Cleerly Labs | Cleerly, Inc. | 2019-11-05 | 216 | 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