Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mistogen Equipment Co. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801619 | MIST2GEN TEMPTROL 10 | Mistogen Equipment Co. | 1980-08-04 | 20 | 0 |
| K781591 | NEBULIZER/HUMIDIFIER MODEL EH 147B | Mistogen Equipment Co. | 1978-10-16 | 28 | 0 |
| K770984 | TA-2 TEMPERATURE ALARM | Mistogen Equipment Co. | 1977-07-05 | 35 | 0 |
| K760341 | HUMIDIFIER, ELECTRONIC (EH147) | Mistogen Equipment Co. | 1976-08-11 | 12 | 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