Atlas FDA

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

Prugen IP Holdings, Inc. · Predicate Candidate Screening

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

119 daysmedian FDA review time
261 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113774HPR PLUS EMOLLIENT FOAMPrugen IP Holdings, Inc.2012-02-09490
K113772HPR EMOLLIENT FOAMPrugen IP Holdings, Inc.2012-02-09490
K110732EMULSION SBPrugen IP Holdings, Inc.2011-06-03790
K093159PR CREAMPrugen IP Holdings, Inc.2010-06-242610
K093156PRUCLAIR NONSTEROIDAL CREAMPrugen IP Holdings, Inc.2010-06-242610
K092878PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBEPrugen IP Holdings, Inc.2010-01-151190

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