Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Dima Italia Srl — Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140598PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERCDima Italia Srl2014-10-162200
K140605MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERCDima Italia Srl2014-10-032070
K072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia Srl2008-05-292870
K072292NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUSDima Italia Srl2008-01-071440

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