FDA applicant
Titan Condoms, LLC
FDA records 2 decisions for Titan Condoms, LLC (San Mateo, CA) from 1997 to 2022: 2 510(k) clearances. All are in product code HIS (Condom). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Titan Condoms”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Titan Condoms, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Titan Condoms, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Titan”
FDA records each applicant name separately; these may or may not be the same firm.