Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ascend Eagle, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101351 | NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GL | Ascend Eagle, Inc. | 2010-10-15 | 154 | 0 |
| K092472 | NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAM | Ascend Eagle, Inc. | 2010-04-15 | 246 | 0 |
| K052666 | NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOV | Ascend Eagle, Inc. | 2006-01-25 | 120 | 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