Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Globe Corporation · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
189 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153264 | EasyPass Guidewire | Medi-Globe Corporation | 2016-05-19 | 189 | 0 |
| K142258 | PolyCatch Retrieval Device | Medi-Globe Corporation | 2014-09-30 | 47 | 0 |
| K133763 | SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM | Medi-Globe Corporation | 2014-05-15 | 155 | 0 |
| K091257 | MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM | Medi-Globe Corporation | 2009-05-08 | 9 | 0 |
| K083802 | SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01- | Medi-Globe Corporation | 2009-03-20 | 88 | 0 |
| K070129 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Medi-Globe Corporation | 2007-01-31 | 15 | 0 |
| K061684 | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME | Medi-Globe Corporation | 2006-06-27 | 12 | 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