Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Empire Plastics Manufacturer · 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) |
|---|---|---|---|---|---|
| K792573 | ALARM USED W/MONITORING SPIROMETER | Empire Plastics Manufacturer | 1979-12-31 | 18 | 0 |
| K792571 | COUNTER UNIT | Empire Plastics Manufacturer | 1979-12-19 | 6 | 0 |
| K792572 | EMPIRE SPIROMETER | Empire Plastics Manufacturer | 1979-12-19 | 6 | 0 |
| K790744 | LUNG FUNCTION AMPLIFIER EXERCISER | Empire Plastics Manufacturer | 1979-04-27 | 11 | 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