Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U.O. 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) |
|---|---|---|---|---|---|
| K862194 | INHALATOR MODELS 8100, 10100 AND 10200 | U.O. Equipment Co. | 1986-07-28 | 49 | 0 |
| K862193 | # 10099/10225/10235/10275/10525/10625/10715/10125 | U.O. Equipment Co. | 1986-07-09 | 30 | 0 |
| K862192 | RESUSCITATOR MODELS 10400/10500/10600/10700/10800 | U.O. Equipment Co. | 1986-07-07 | 28 | 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