Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Easyglide , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
216 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113050 | CLEARPATH LOWER GI | Easyglide , Ltd. | 2012-05-16 | 216 | 0 |
| K113166 | CLEARPATH UPPER GI | Easyglide , Ltd. | 2012-05-16 | 202 | 0 |
| K101094 | CLEARJET | Easyglide , Ltd. | 2010-05-17 | 27 | 0 |
| K093779 | CLEARPATH UGI | Easyglide , Ltd. | 2010-03-09 | 90 | 0 |
| K091305 | CLEARPATH | Easyglide , Ltd. | 2009-10-23 | 172 | 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