Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trudell Medical Int'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) |
|---|---|---|---|---|---|
| K140919 | RESPICONNECT ADAPTER | Trudell Medical Int'L | 2014-08-15 | 127 | 0 |
| K001137 | AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) | Trudell Medical Int'L | 2000-07-05 | 86 | 0 |
| K992917 | AEROCHAMBER PLUS VALVED HOLDING CHAMBER | Trudell Medical Int'L | 1999-09-14 | 15 | 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