Atlas FDA

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

Remed Pharma · Predicate Candidate Screening

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

130 daysmedian FDA review time
315 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K993389REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BORemed Pharma2000-08-183150
K993403REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKYRemed Pharma2000-08-183150
K993409REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BORemed Pharma2000-08-183150
K993395REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BORemed Pharma2000-02-151300
K993396REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIRemed Pharma2000-02-151300
K993404REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND Remed Pharma2000-02-151300
K993405REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMITRemed Pharma2000-02-151300
K993408REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMITRemed Pharma2000-02-151300
K993390REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, Remed Pharma2000-02-141290

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