Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cadema Medical Products, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
1821 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K901476 | MODIFIED ENTRAPPING FILTER | Cadema Medical Products, Inc. | 1990-05-01 | 41 | 0 |
| K896773 | DISPOSABLE FACE MASK | Cadema Medical Products, Inc. | 1990-01-12 | 42 | 0 |
| K896116 | ENTRAPPING FILTER | Cadema Medical Products, Inc. | 1989-11-17 | 28 | 0 |
| K881812 | AERO-MIST NEBULIZER | Cadema Medical Products, Inc. | 1988-07-18 | 81 | 0 |
| K873930 | AEROSOL DELIVERY SYSTEM (AERO-TECH II) | Cadema Medical Products, Inc. | 1987-12-07 | 73 | 0 |
| K800023 | LUNG AEROSOL UNIT | Cadema Medical Products, Inc. | 1985-01-01 | 1821 | 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