Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clear Guide Medical — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
185 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234030 | Clear Guide SCENERGY | Clear Guide Medical | 2024-01-17 | 28 | 0 |
| K201188 | Clear Guide SCENERGY | Clear Guide Medical | 2020-09-30 | 152 | 0 |
| K201898 | Clear Guide SCENERGY | Clear Guide Medical | 2020-07-31 | 29 | 0 |
| K171677 | Clear Guide SCENERGY | Clear Guide Medical | 2017-12-08 | 185 | 0 |
| K153004 | Clear Guide SCENERGY | Clear Guide Medical | 2016-02-12 | 122 | 0 |
| K141806 | CLEAR GUIDE ONE | Clear Guide Medical | 2014-09-19 | 78 | 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