Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eagle Medical, 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) |
|---|---|---|---|---|---|
| K933661 | INSUFFLATOR TUBING KIT W/FILTER | Eagle Medical, Inc. | 1993-08-25 | 29 | 0 |
| K915591 | STERILE GAUZE PADS | Eagle Medical, Inc. | 1993-01-27 | 411 | 0 |
| K891795 | DISPOSABLE LATEX EXAM GLOVES | Eagle Medical, Inc. | 1989-04-26 | 34 | 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