Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med2000 S.R.L. · 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) |
|---|---|---|---|---|---|
| K041974 | MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZ | Med2000 S.R.L. | 2004-08-24 | 33 | 0 |
| K041327 | MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES | Med2000 S.R.L. | 2004-07-20 | 63 | 0 |
| K031908 | MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NE | Med2000 S.R.L. | 2004-01-14 | 208 | 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