Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Airon Corporation · 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) |
|---|---|---|---|---|---|
| K121379 | PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATIO | Airon Corporation | 2012-10-11 | 156 | 0 |
| K080692 | MACS CPAP SYSTEM | Airon Corporation | 2008-06-20 | 101 | 0 |
| K043085 | MODIFICATION TO: PNEUTON VENTILATOR | Airon Corporation | 2004-12-20 | 42 | 0 |
| K024344 | PNEUTON VENTILATOR | Airon Corporation | 2003-06-03 | 158 | 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