Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Industrias Palex C/O Dma Med-Chem Corp. · Predicate Candidate Screening

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

58 daysmedian FDA review time
747 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K920740EPISENSOR PLUSIndustrias Palex C/O Dma Med-Chem Corp.1994-03-077470
K920366ULCUFLEX HYDROCOLOID POWDERIndustrias Palex C/O Dma Med-Chem Corp.1992-03-26580
K920367ULCUFLEX HYDROCULLOID DRESSINGIndustrias Palex C/O Dma Med-Chem Corp.1992-03-26580
K920368ULCUFLEX HYDROCOLLOID PASTEIndustrias Palex C/O Dma Med-Chem Corp.1992-03-26580
K871628PALEX (R) OSTOMYIndustrias Palex C/O Dma Med-Chem Corp.1987-07-08720

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