Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Globe Ent., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972839 | PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFU | Globe Ent., Inc. | 1997-12-17 | 138 | 0 |
| K972854 | PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROP | Globe Ent., Inc. | 1997-12-17 | 138 | 0 |
| K972843 | PROTOS BLOOD TRANSFUSION SET | Globe Ent., Inc. | 1997-12-16 | 137 | 0 |
| K892623 | PATIENT EXAMINATION GLOVES (LATEX) | Globe Ent., Inc. | 1989-09-11 | 154 | 0 |
| K884622 | SURGICAL GLOVES | Globe Ent., Inc. | 1989-03-14 | 130 | 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