Atlas FDA

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

Argentum International, LLC — Predicate Candidate Screening

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

304 daysmedian FDA review time
3037 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K984204SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIPArgentum International, LLC2007-03-1930370
K984207SILVERLON DIRECT PRESSURE WOUND DRESSINGArgentum International, LLC2007-03-1930370
K984205SILVERLON ADHESIVE STRIPArgentum International, LLC2007-03-1930370
K023612SILVERLON CONTACT WOUND DRESSINGArgentum International, LLC2003-01-24880
K023609SILVERLON ADHESIVE STRIPArgentum International, LLC2003-01-17810
K984210SILVERLON WOUND PACKING STRIPSArgentum International, LLC1999-09-243040
K984208SILVERLON ISLAND DRESSING, SILVERLON ISLAND PADArgentum International, LLC1999-02-22900
K981299SILVERLON CONTACT WOUND DRESSINGArgentum International, LLC1998-09-251690

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