Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hmi Industries, Inc. · 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) |
|---|---|---|---|---|---|
| K010616 | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | Hmi Industries, Inc. | 2001-03-28 | 27 | 0 |
| K002692 | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A | Hmi Industries, Inc. | 2000-11-17 | 80 | 0 |
| K921797 | PRECI-JET 50 | Hmi Industries, Inc. | 1992-11-17 | 217 | 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