FDA 510(k)

Titan Condoms

K-Number: K210208 · 2022-02-17

Decision Date2022-02-17

Product CodeHIS

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Titan Condoms is the device name listed in this FDA 510(k) record. The listed applicant is Titan Condoms, LLC. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K210208. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Titan Condoms?

Titan Condoms is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Titan Condoms, LLC. The 510(k) number is K210208.

When did Titan Condoms receive FDA 510(k) clearance?

Titan Condoms received FDA 510(k) clearance on 2022-02-17, under 510(k) number K210208.

Who is the listed applicant for Titan Condoms?

The FDA 510(k) record lists Titan Condoms, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Titan Condoms?

The FDA product code for Titan Condoms is HIS.

Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex Limited K250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.K2435840.04 ZERO ZERO FOUR Male Latex CondomOkamoto USA, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.