510(k) Report

FDA applicant

Titan Condoms, LLC

San Mateo, CA2 decisions1997–20220 recalls

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, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Titan Condoms, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Titan Condoms, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Titan”

FDA records each applicant name separately; these may or may not be the same firm.