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510(k) Clearances

Manufacturers do not need to obtain FDA 510(k) clearances to market external penile rigidity devices in the U.S.

Fact-Checks

2 results
Feb 6, 2026

What lab standards exist for lubricant-toy compatibility and how often are commercial lubes tested to those standards?

Laboratory standards that directly address personal-lubricant compatibility with sexual-health products exist, most notably D7661 for natural rubber latex condoms, and international guidance (/) cites...

Jan 17, 2026

Which manufacturers currently hold FDA 510(k) clearances for external penile rigidity devices and what are their 510(k) numbers?

The FDA has classified external penile rigidity devices as Class II but has determined they are exempt from the premarket notification (510(k)) requirement, meaning manufacturers do not need to obtain...