Atlas FDA

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

Regent Medical Americas, LLC · Predicate Candidate Screening

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

88 daysmedian FDA review time
126 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVERegent Medical Americas, LLC2006-04-101220
K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVERegent Medical Americas, LLC2006-03-101260
K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVERegent Medical Americas, LLC2006-03-07880
K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGERegent Medical Americas, LLC2006-02-01540
K050899BIOGEL LATEX STERILE POWDER-FREE GLOVERegent Medical Americas, LLC2005-08-121230
K050533ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVERegent Medical Americas, LLC2005-04-26550
K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVERegent Medical Americas, LLC2005-03-16480

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