Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Air Safety, Ltd. · 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) |
|---|---|---|---|---|---|
| K051712 | MODEL 2800 PFT FILTER | Air Safety, Ltd. | 2005-09-01 | 66 | 0 |
| K050953 | AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE | Air Safety, Ltd. | 2005-06-29 | 75 | 0 |
| K040712 | AIR SAFETY HEPA, MODEL 3500 | Air Safety, Ltd. | 2004-06-03 | 77 | 0 |
| K033008 | AIR SAFETY HEPA AND NON-HEPA FILTERS | Air Safety, Ltd. | 2004-05-13 | 230 | 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