Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eagle Medical Equipment Co. · 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) |
|---|---|---|---|---|---|
| K062724 | ACCUPULSE PULSE OXIMETER | Eagle Medical Equipment Co. | 2007-05-11 | 241 | 0 |
| K955129 | OXYPULSE EOC I, EOC II & EOC R | Eagle Medical Equipment Co. | 1996-02-16 | 99 | 0 |
| K831819 | OXYGEN CONCENTRATOR RESPIRATORY SUPPOR | Eagle Medical Equipment Co. | 1983-11-22 | 169 | 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