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

1. The regulatory determination: class II with exemption, not a 510(k) pathway

The Federal Register and FDA guidance establish that external penile rigidity devices are Class II devices subject to special controls, but the agency explicitly exempted them from premarket notification requirements under section 510(k), concluding that premarket notification is not necessary to assure their safety and effectiveness ^[1]. The FDA guidance reiterates that persons who intend to market this device type do not need to submit a 510(k) and receive agency clearance prior to marketing, while also advising manufacturers how to meet special controls and quality system expectations ^[2].

2. Consequence for “who holds 510(k) clearances”: none implied by the sources

Because the FDA’s formal classification and guidance state that external penile rigidity devices are exempt from 510(k) premarket notification, the supplied material implies there is no regulatory requirement for a manufacturer to hold a 510(k) clearance for these devices, and therefore no authoritative list of 510(k) numbers tied to this device type is provided in the documents supplied ^{[1] [2]}. The guidance even states that conforming to the special control guidance allows marketing without 510(k) review ^[2].

3. How to confirm — databases and practical verification steps

The FDA maintains a releasable 510(k) database and monthly listings of 510(k)s that can be searched by product code, device name, or 510(k) number; an independent search of that database would be required to identify any voluntary 510(k) submissions or anomalous listings ^{[3] [4]}. The current reporting does not include the results of such a database search, so while the regulatory status points away from 510(k) clearances being necessary or typical for these devices, this review cannot categorically rule out that a manufacturer may have voluntarily submitted a 510(k) for a product with overlapping features without those results being present in the provided sources ^[3].

4. Alternative viewpoints, commercial incentives and possible exceptions

Manufacturers sometimes elect to pursue a 510(k) voluntarily for market confidence, payer acceptance, or to claim “FDA-cleared” status even when not required; the supplied sources do not document any such voluntary clearances for external penile rigidity devices, but they do not preclude private strategies to seek clearance ^{[2] [3]}. Regulatory documents and industry guidance also acknowledge that manufacturers may choose restricted distribution through professional channels and work with physicians, which suggests a commercial incentive to follow special controls and quality systems even absent 510(k) requirements ^[2].

5. Final answer and transparency about limits of the reporting

Based on the FDA classification and guidance in the provided reporting, external penile rigidity devices are exempt from the 510(k) requirement and therefore the sources do not identify any manufacturers as holding FDA 510(k) clearances or list any 510(k) numbers for such devices; to definitively confirm the existence of any voluntary 510(k) clearances would require querying the FDA releasable 510(k) database or monthly listings directly, a step not performed in the supplied material ^{[1] [2] [3]}. The available documents support the conclusion that there are no mandatory 510(k) clearances for this device class and no 510(k) numbers are presented in the sources provided ^{[1] [2]}.