Atlas FDA

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

Innolatex Sdn. Bhd · Predicate Candidate Screening

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

80 daysmedian FDA review time
134 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K053367MALE NATURAL RUBBER LATEX CONDOMInnolatex Sdn. Bhd2006-02-21780
K041837INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTEDInnolatex Sdn. Bhd2004-09-24790
K012962DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOMInnolatex Sdn. Bhd2001-11-09660
K012665ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANTInnolatex Sdn. Bhd2001-11-09880
K012664ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANTInnolatex Sdn. Bhd2001-11-09880
K01296456MM CONDOM,MALE NATURAL RUBBER LATEX CONDOMInnolatex Sdn. Bhd2001-11-09660
K010919MALE NATURAL RUBBER LATEX CONDOMInnolatex Sdn. Bhd2001-06-15800
K010178SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. Bhd2001-04-27980
K002393NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. Bhd2000-12-191340

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